The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Corning Cell Wells-multiple Well Plates.
Device ID | K853634 |
510k Number | K853634 |
Device Name: | CORNING CELL WELLS-MULTIPLE WELL PLATES |
Classification | Dish, Tissue Culture |
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 | KIZ |
CFR Regulation Number | 864.2240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-08-30 |
Decision Date | 1985-09-16 |