O. B. PACK I— 510(k) K902271
Substantially EquivalentCustomed, Inc.
FDA 510(k) clearance K902271 for O. B. PACK I, Substantially Equivalent on 1990-08-15. Applicant: Customed, Inc.. Device class: 1.
Clearance details
- Applicant
- Customed, Inc.
- Product code
- Code HHD
- Device class
- Class 1
- Regulation
- 21 CFR 884.5435
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carolina Puerto Rico, US
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Recalls naming K902271
K-number listed on FDA's recall record- Z-1399-2016 — Catalog Number: 900012 OB SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Z-1464-2016 — Catalog Number: 9002940 OBSTETRICAL SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Z-2550-2015 — O.B. PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Z-2604-2015 — O.B. PACK 4/CS REV. Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
- Z-2661-2015 — OBSTETRICAL SURGICAL PACK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K902271.
Data sourced from openFDA. This site is unofficial and independent of the FDA.