The following data is part of a premarket notification filed by Arch Development Group with the FDA for Sterilesert(tm) Cable And Pole Drape.
| Device ID | K913047 |
| 510k Number | K913047 |
| Device Name: | STERILESERT(TM) CABLE AND POLE DRAPE |
| Classification | Drape, Surgical |
| Applicant | ARCH DEVELOPMENT GROUP 9648 OLIVE BLVD., SUITE 411 St. Louis, MO 63132 |
| Contact | Robert A Roth |
| Correspondent | Robert A Roth ARCH DEVELOPMENT GROUP 9648 OLIVE BLVD., SUITE 411 St. Louis, MO 63132 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-09 |
| Decision Date | 1991-10-02 |