The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Corning Disposal Sterile Filter System-nylon.
Device ID | K844671 |
510k Number | K844671 |
Device Name: | CORNING DISPOSAL STERILE FILTER SYSTEM-NYLON |
Classification | Filters, Cell Collection, Tissue Processing |
Applicant | CORNING MEDICAL & SCIENTIFIC CORNING GLASS WORKS Medfield, MA 02052 |
Contact | William J Plgnato |
Correspondent | William J Plgnato CORNING MEDICAL & SCIENTIFIC CORNING GLASS WORKS Medfield, MA 02052 |
Product Code | KET |
CFR Regulation Number | 864.3010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-11-30 |
Decision Date | 1985-02-25 |