CARAPACE LABOR AND DELIVERY SETS
FDA 510(k) clearance K931722 · decided 1994-03-23
Clearance details
- K-number
- K931722
- Device name
- CARAPACE LABOR AND DELIVERY SETS
- Applicant
- Carapace, Inc.
- Decision
- Unknown
- Date received
- 1993-04-07
- Decision date
- 1994-03-23
- Days to decision
- 350 days
- Clearance type
- Traditional
- Product code
- MLS
- Device class
- 2
- Regulation number
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Broken Arrow, OK, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT) (K961993) | Devon Industries, Inc. | 1996-07-03 |
| CPR C-SECTION DELIVERY PACK (K960243) | Custom Pack Reliability | 1996-05-23 |
| C-SECTION TRAY (K940518) | Cush Medical Products | 1994-08-18 |
| C-SECTION, LABOR & DELIVERY TRAYS (PACKS) (K932216) | Associated Medical Products Co. | 1994-04-19 |
| LABOR AND DELIVERY TRAY (K936120) | Cush Medical Products | 1994-03-30 |
Recalls involving this device
No recalls on record reference this clearance.