The following data is part of a premarket notification filed by Medikmark, Inc. with the FDA for C-section Pack.
| Device ID | K921730 |
| 510k Number | K921730 |
| Device Name: | C-SECTION PACK |
| Classification | Instrument, Manual, General Obstetric-gynecologic |
| Applicant | MEDIKMARK, INC. 333 WEST WACKER DR. SUITE 2600 Chicago, IL 60606 |
| Contact | Richard O Wood |
| Correspondent | Richard O Wood MEDIKMARK, INC. 333 WEST WACKER DR. SUITE 2600 Chicago, IL 60606 |
| Product Code | KOH |
| CFR Regulation Number | 884.4520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-10 |
| Decision Date | 1994-06-15 |