The following data is part of a premarket notification filed by S.c. Johnson & Son, Inc. with the FDA for Compres Portable Heat Pads.
Device ID | K821046 |
510k Number | K821046 |
Device Name: | COMPRES PORTABLE HEAT PADS |
Classification | Pack, Hot Or Cold, Disposable |
Applicant | S.C. JOHNSON & SON, INC. 2515 WILLOW RD. Sturtevant, WI 53177 |
Product Code | IMD |
CFR Regulation Number | 890.5710 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-04-14 |
Decision Date | 1982-04-29 |