The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Disposable Sterile Filter System.
Device ID | K831450 |
510k Number | K831450 |
Device Name: | DISPOSABLE STERILE FILTER SYSTEM |
Classification | Device, General Purpose, Microbiology, Diagnostic |
Applicant | CORNING MEDICAL & SCIENTIFIC 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | LIB |
CFR Regulation Number | 866.2660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-05-05 |
Decision Date | 1983-06-02 |