The following data is part of a premarket notification filed by Infection Control Products, Inc. with the FDA for Fluid Soakershield.
Device ID | K900643 |
510k Number | K900643 |
Device Name: | FLUID SOAKERSHIELD |
Classification | Bedding, Disposable, Medical |
Applicant | INFECTION CONTROL PRODUCTS, INC. P.O. DRAWER 739 1019 GRUBBS AVENUE Gardendale, AL 35071 |
Contact | John P Russell |
Correspondent | John P Russell INFECTION CONTROL PRODUCTS, INC. P.O. DRAWER 739 1019 GRUBBS AVENUE Gardendale, AL 35071 |
Product Code | KME |
CFR Regulation Number | 880.6060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-02-09 |
Decision Date | 1990-04-25 |