The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Disposable Sterile Syringe Filters.
Device ID | K875122 |
510k Number | K875122 |
Device Name: | DISPOSABLE STERILE SYRINGE FILTERS |
Classification | Filters, Cell Collection, Tissue Processing |
Applicant | CORNING MEDICAL & SCIENTIFIC 275 RIVER ST. Oneonta, NY 13820 |
Contact | Barbara L Mullin |
Correspondent | Barbara L Mullin CORNING MEDICAL & SCIENTIFIC 275 RIVER ST. Oneonta, NY 13820 |
Product Code | KET |
CFR Regulation Number | 864.3010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-12-15 |
Decision Date | 1988-01-12 |