The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Corning Blood Collection Capillary Tubes.
Device ID | K850806 |
510k Number | K850806 |
Device Name: | CORNING BLOOD COLLECTION CAPILLARY TUBES |
Classification | Tube, Collection, Capillary Blood |
Applicant | CORNING MEDICAL & SCIENTIFIC CORNING GLASS WORKS Medfield, MA 02052 |
Contact | William J Pignato |
Correspondent | William J Pignato CORNING MEDICAL & SCIENTIFIC CORNING GLASS WORKS Medfield, MA 02052 |
Product Code | GIO |
CFR Regulation Number | 864.6150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-02-27 |
Decision Date | 1985-03-25 |