The following data is part of a premarket notification filed by Tecnol New Jersey Wound Care, Inc. with the FDA for Tecnol Patient Use Ice Pack.
| Device ID | K760782 |
| 510k Number | K760782 |
| Device Name: | TECNOL PATIENT USE ICE PACK |
| Classification | Pack, Hot Or Cold, Water Circulating |
| Applicant | TECNOL NEW JERSEY WOUND CARE, INC. 368 FAIRVIEW AVE. Hammonton, NJ 08037 -0268 |
| Product Code | ILO |
| CFR Regulation Number | 890.5720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-10-05 |
| Decision Date | 1976-12-02 |