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 |