CUSTOMED LAP PACK I— 510(k) K902029
Substantially EquivalentCustomed, Inc.
FDA 510(k) clearance K902029 for CUSTOMED LAP PACK I, Substantially Equivalent on 1990-07-12. 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
- Fajardo, PR, US
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Recalls naming K902029
K-number listed on FDA's recall record- Z-1418-2016 — Catalog Number: 9001296 PREMIUM LAPAROTOMY PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Z-1477-2016 — Catalog Number: 900547 BASIC SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Z-1494-2016 — Catalog Number: 900996 LAPAROTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Z-2686-2015 — LAPAROTOMY BASIC PACK 10/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 K902029.
Data sourced from openFDA. This site is unofficial and independent of the FDA.