O. B. PACK IV
FDA 510(k) clearance K902032 · decided 1990-09-28
Clearance details
- K-number
- K902032
- Device name
- O. B. PACK IV
- Applicant
- Customed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-05-04
- Decision date
- 1990-09-28
- Days to decision
- 147 days
- Clearance type
- Traditional
- Product code
- HFC
- Device class
- 2
- Regulation number
- 884.1050
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Fajardo, PR, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Catalog Number: 9001297 PREMIUM OBSTETRICAL SURGICAL PACK Used by medical staff to perform recall (Z-1419-2016) | Customed, Inc | 2016-04-14 |
| CESAREAN PACK 4/CS Used by medical staff to perform surgical procedures and patient care p recall (Z-2605-2015) | Customed, Inc | 2015-09-03 |