The following data is part of a premarket notification filed by Ultimate Wireforms, Inc. with the FDA for Ortho-ice.
| Device ID | K960799 |
| 510k Number | K960799 |
| Device Name: | ORTHO-ICE |
| Classification | Tester, Pulp |
| Applicant | ULTIMATE WIREFORMS, INC. 200 CENTRAL ST. Bristol, CT 06010 |
| Contact | Donald F Pelletier |
| Correspondent | Donald F Pelletier ULTIMATE WIREFORMS, INC. 200 CENTRAL ST. Bristol, CT 06010 |
| Product Code | EAT |
| CFR Regulation Number | 872.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-27 |
| Decision Date | 1996-05-09 |