The following data is part of a premarket notification filed by Consolidated Products & Services, Inc. with the FDA for Cp&s Disposable Instant Super Hot Compress.
Device ID | K890554 |
510k Number | K890554 |
Device Name: | CP&S DISPOSABLE INSTANT SUPER HOT COMPRESS |
Classification | Pack, Hot Or Cold, Disposable |
Applicant | CONSOLIDATED PRODUCTS & SERVICES, INC. 30 FAYETTE ST. North Quincy, MA 02171 |
Contact | Richard Mcmanus |
Correspondent | Richard Mcmanus CONSOLIDATED PRODUCTS & SERVICES, INC. 30 FAYETTE ST. North Quincy, MA 02171 |
Product Code | IMD |
CFR Regulation Number | 890.5710 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-02-06 |
Decision Date | 1989-02-13 |