The following data is part of a premarket notification filed by American White Cross, Inc. with the FDA for Ultrafera Wound Dressing.
| Device ID | K964614 |
| 510k Number | K964614 |
| Device Name: | ULTRAFERA WOUND DRESSING |
| Classification | Bandage, Liquid |
| Applicant | AMERICAN WHITE CROSS, INC. 349 LAKE RD. Dayville, CT 06241 |
| Contact | Paul B Callahan |
| Correspondent | Paul B Callahan AMERICAN WHITE CROSS, INC. 349 LAKE RD. Dayville, CT 06241 |
| Product Code | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-18 |
| Decision Date | 1997-02-06 |