The following data is part of a premarket notification filed by American White Cross, Inc. with the FDA for Awc Butterfly Wound Closures.
| Device ID | K894802 |
| 510k Number | K894802 |
| Device Name: | AWC BUTTERFLY WOUND CLOSURES |
| Classification | Strip, Adhesive, Closure, Skin |
| Applicant | AMERICAN WHITE CROSS, INC. BOX L New Rochelle, NY 10802 |
| Contact | Jack Orentzel |
| Correspondent | Jack Orentzel AMERICAN WHITE CROSS, INC. BOX L New Rochelle, NY 10802 |
| Product Code | FPX |
| CFR Regulation Number | 880.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-28 |
| Decision Date | 1990-01-31 |