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 |