The following data is part of a premarket notification filed by Continental Medical Laboratories, Inc. with the FDA for Prod No. 01-1694 - 4x4 Foam Dressing.
| Device ID | K954728 |
| 510k Number | K954728 |
| Device Name: | PROD NO. 01-1694 - 4X4 FOAM DRESSING |
| Classification | Bandage, Liquid |
| Applicant | CONTINENTAL MEDICAL LABORATORIES, INC. P.O. BOX 306 817 MOHR AVENUE Waterford, WI 53185 |
| Contact | Joseph Dunn |
| Correspondent | Joseph Dunn CONTINENTAL MEDICAL LABORATORIES, INC. P.O. BOX 306 817 MOHR AVENUE Waterford, WI 53185 |
| Product Code | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-13 |
| Decision Date | 1996-09-23 |