The following data is part of a premarket notification filed by Com-med International, Inc. with the FDA for Com-med O.r. Towel - Non-sterile, Blue, Green, White.
| Device ID | K002691 |
| 510k Number | K002691 |
| Device Name: | COM-MED O.R. TOWEL - NON-STERILE, BLUE, GREEN, WHITE |
| Classification | Drape, Surgical |
| Applicant | COM-MED INTERNATIONAL, INC. P.O. BOX 848 Grayslake, IL 60030 |
| Contact | Michele Vovolka |
| Correspondent | Michele Vovolka COM-MED INTERNATIONAL, INC. P.O. BOX 848 Grayslake, IL 60030 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-29 |
| Decision Date | 2000-12-08 |