The following data is part of a premarket notification filed by Banta Healthcare Group, Ltd. with the FDA for Tidi Brand Sterilization Wrap.
| Device ID | K042580 |
| 510k Number | K042580 |
| Device Name: | TIDI BRAND STERILIZATION WRAP |
| Classification | Wrap, Sterilization |
| Applicant | BANTA HEALTHCARE GROUP, LTD. 2454 MCMULLEN BOOTH RD. Clearwater, FL 33759 |
| Contact | Ina Gordon |
| Correspondent | Tamas Borsai TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-09-22 |
| Decision Date | 2004-11-17 |
| Summary: | summary |