The following data is part of a premarket notification filed by Hydro-med Products, Inc. with the FDA for Thera-pak.
| Device ID | K780452 |
| 510k Number | K780452 |
| Device Name: | THERA-PAK |
| Classification | Pack, Hot Or Cold, Water Circulating |
| Applicant | HYDRO-MED PRODUCTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | ILO |
| CFR Regulation Number | 890.5720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-03-21 |
| Decision Date | 1978-06-21 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() THERA-PAK 74051359 not registered Dead/Abandoned |
All-Gel Corporation 1990-04-23 |
![]() THERA-PAK 73636913 1451738 Dead/Cancelled |
CONTINENTAL GRAIN COMPANY 1986-12-22 |