The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Corning 101 Printer.
Device ID | K822146 |
510k Number | K822146 |
Device Name: | CORNING 101 PRINTER |
Classification | Calculator/data Processing Module, For Clinical Use |
Applicant | CORNING MEDICAL & SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JQP |
CFR Regulation Number | 862.2100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-07-21 |
Decision Date | 1982-08-05 |