CUSTOMED LAP PACK IV
FDA 510(k) clearance K902031 · decided 1990-07-12
Clearance details
- K-number
- K902031
- Device name
- CUSTOMED LAP PACK IV
- Applicant
- Customed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-05-04
- Decision date
- 1990-07-12
- Days to decision
- 69 days
- Clearance type
- Traditional
- Product code
- KKX
- Device class
- 2
- Regulation number
- 878.4370
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Fajardo, PR, US
- Third-party review
- No
- Expedited review
- No
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