The following data is part of a premarket notification filed by Advance Medical Designs, Inc. with the FDA for Or Towel Packs.
| Device ID | K894764 |
| 510k Number | K894764 |
| Device Name: | OR TOWEL PACKS |
| Classification | Drape, Surgical |
| Applicant | ADVANCE MEDICAL DESIGNS, INC. 808 PICKENS INDUSTRIAL DR. Marietta, GA 30062 |
| Contact | Thomas E Cottone |
| Correspondent | Thomas E Cottone ADVANCE MEDICAL DESIGNS, INC. 808 PICKENS INDUSTRIAL DR. Marietta, GA 30062 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-27 |
| Decision Date | 1989-08-18 |