The following data is part of a premarket notification filed by Keeler Instruments, Inc. with the FDA for Cryomatic Cryo Console, Disposable Cryo Probe, Disposable Probe Adapter.
Device ID | K112093 |
510k Number | K112093 |
Device Name: | CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER |
Classification | Unit, Cryophthalmic, Ac-powered |
Applicant | KEELER INSTRUMENTS, INC. 456 PKWY. Broomall, PA 19008 |
Contact | Eugene R Vanarsdale |
Correspondent | Eugene R Vanarsdale KEELER INSTRUMENTS, INC. 456 PKWY. Broomall, PA 19008 |
Product Code | HRN |
CFR Regulation Number | 886.4170 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-07-22 |
Decision Date | 2011-12-08 |