The following data is part of a premarket notification filed by American Threshold Industries, Inc. with the FDA for Nova Gauze(r) Disposable Nonwoven Sponges, Sterile.
| Device ID | K915530 |
| 510k Number | K915530 |
| Device Name: | NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE |
| Classification | Tong, Skull For Traction |
| Applicant | AMERICAN THRESHOLD INDUSTRIES, INC. 240 SARDIS RD. P.O. BOX 1209 Enka, NC 28728 |
| Contact | Robert T Bayer |
| Correspondent | Robert T Bayer AMERICAN THRESHOLD INDUSTRIES, INC. 240 SARDIS RD. P.O. BOX 1209 Enka, NC 28728 |
| Product Code | HAX |
| CFR Regulation Number | 882.5960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-10 |
| Decision Date | 1992-08-17 |