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 |