CUSTOMED LAP PACK II— 510(k) K902191
Substantially EquivalentCustomed, Inc.
FDA 510(k) clearance K902191 for CUSTOMED LAP PACK II, Substantially Equivalent on 1990-10-31. Applicant: Customed, Inc.. Device class: 2.
Clearance details
- Applicant
- Customed, Inc.
- Product code
- Code KKX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4370
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carolina Puerto Rico, US
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Recalls naming K902191
K-number listed on FDA's recall record- Z-1489-2016 — Catalog Number: 900796 FEMORAL ANGIOGRAPHY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Z-2590-2015 — LAPAROTOMY 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-2705-2015 — FEMORAL ANGIOGRAPHY 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 K902191.
Data sourced from openFDA. This site is unofficial and independent of the FDA.