The following data is part of a premarket notification filed by Hospital Marketing Services Co., Inc. with the FDA for Cold-hot Pack.
Device ID | K820068 |
510k Number | K820068 |
Device Name: | COLD-HOT PACK |
Classification | Pack, Hot Or Cold, Reusable |
Applicant | HOSPITAL MARKETING SERVICES CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IME |
CFR Regulation Number | 890.5700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-01-12 |
Decision Date | 1982-01-28 |