CPR C-SECTION DELIVERY PACK
FDA 510(k) clearance K960243 · decided 1996-05-23
Clearance details
- K-number
- K960243
- Device name
- CPR C-SECTION DELIVERY PACK
- Applicant
- Custom Pack Reliability
- Decision
- Substantially Equivalent
- Date received
- 1996-01-16
- Decision date
- 1996-05-23
- Days to decision
- 128 days
- Clearance type
- Traditional
- Product code
- MLS
- Device class
- 2
- Regulation number
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Orlando, FL, 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 |
| 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 |
| CARAPACE LABOR AND DELIVERY SETS (K931722) | Carapace, Inc. | 1994-03-23 |
Recalls involving this device
No recalls on record reference this clearance.