The following data is part of a premarket notification filed by Medikmark, Inc. with the FDA for Upper Extermity Drape Kit.
| Device ID | K923960 |
| 510k Number | K923960 |
| Device Name: | UPPER EXTERMITY DRAPE KIT |
| Classification | Drape, Surgical |
| 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 | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-06 |
| Decision Date | 1994-10-07 |