O. B. PACK III— 510(k) K902273
Substantially EquivalentCustomed, Inc.
FDA 510(k) clearance K902273 for O. B. PACK III, Substantially Equivalent on 1990-08-21. 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 K902273
K-number listed on FDA's recall record- Z-1417-2016 — Catalog Number: 9001294 PREMIUM CESAREAN PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Z-1432-2016 — Catalog Number: 900168 LABOR & DELIVERY SURGICAL PACK 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 K902273.
Data sourced from openFDA. This site is unofficial and independent of the FDA.