The following data is part of a premarket notification filed by Corning Costar Corp. with the FDA for Cell Lifter.
Device ID | K871559 |
510k Number | K871559 |
Device Name: | CELL LIFTER |
Classification | Device, General Purpose, Microbiology, Diagnostic |
Applicant | CORNING COSTAR CORP. ALEWIVE RD. Kennebunk, ME 04043 |
Contact | Peter C Sutcliffe |
Correspondent | Peter C Sutcliffe CORNING COSTAR CORP. ALEWIVE RD. Kennebunk, ME 04043 |
Product Code | LIB |
CFR Regulation Number | 866.2660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-04-22 |
Decision Date | 1987-05-15 |