Identifiers
- 510(k) Number
- K902031 FDA 510(k)
- FDA Product Code
- KKX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4370 FDA 510(k)
- Regulation Number
- 878.4370 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Customed Lap Pack IV is a medical device classified under product code KKX and cleared through an FDA 510(k) submission (K902031). The clearance was granted as a traditional submission after a determination of substantial equivalence, and the device was reviewed by the General Plastic Surgery advisory committee.
The device was cleared on July 12, 1990, and is manufactured by Customed, Inc. in Fajardo, Puerto Rico, United States. It is identified by the name Customed Lap Pack IV and the K-number K902031.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: CUSTOMED LAP PACK IV (K902031) — FDA 510(k) | Innolitics, CUSTOMED LAP PACK IV 510 (k) K902031 - FDA.report, PDF K902031 CUSTOMED LAP PACK IV - 510kdatabase.net
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K902031 | Class II | Active |
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Manufacturer
- Manufacturer
- Customed, Inc.
Sources (1)
- FDA 510(k) K902031 24 fields · synced Sep 24, 2026