The following data is part of a premarket notification filed by Keeler Instruments, Inc. with the FDA for Keeler Cryo Master & Probes.
Device ID | K992954 |
510k Number | K992954 |
Device Name: | KEELER CRYO MASTER & PROBES |
Classification | Unit, Cryophthalmic, Ac-powered |
Applicant | KEELER INSTRUMENTS, INC. 456 PKWY. Broomall, PA 19008 |
Contact | Eugene R Van Arsdale |
Correspondent | Eugene R Van Arsdale KEELER INSTRUMENTS, INC. 456 PKWY. Broomall, PA 19008 |
Product Code | HRN |
CFR Regulation Number | 886.4170 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-09-01 |
Decision Date | 1999-12-21 |