The following data is part of a premarket notification filed by American Threshold Industries, Inc. with the FDA for Secure-wrap (tm) Sterilization Wrap.
| Device ID | K971483 |
| 510k Number | K971483 |
| Device Name: | SECURE-WRAP (TM) STERILIZATION WRAP |
| Classification | Wrap, Sterilization |
| Applicant | AMERICAN THRESHOLD INDUSTRIES, INC. 240 SARDIS RD. P.O. BOX 1209 Enka, NC 28728 |
| Contact | Frances Mayhew |
| Correspondent | Frances Mayhew AMERICAN THRESHOLD INDUSTRIES, INC. 240 SARDIS RD. P.O. BOX 1209 Enka, NC 28728 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-23 |
| Decision Date | 1997-06-24 |