The following data is part of a premarket notification filed by Keeler Instruments, Inc. with the FDA for Cryomatic.
Device ID | K062412 |
510k Number | K062412 |
Device Name: | CRYOMATIC |
Classification | Unit, Cryophthalmic, Ac-powered |
Applicant | KEELER INSTRUMENTS, INC. 456 PARKWAY Broomall, PA 19008 |
Contact | Eugene R Vanarsdale |
Correspondent | Eugene R Vanarsdale KEELER INSTRUMENTS, INC. 456 PARKWAY 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 | 2006-08-17 |
Decision Date | 2006-11-06 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05055272707701 | K062412 | 000 |
05055272707695 | K062412 | 000 |
05055272707688 | K062412 | 000 |
05055272707671 | K062412 | 000 |
05055272707664 | K062412 | 000 |
05055272707657 | K062412 | 000 |
05055272707640 | K062412 | 000 |
05055272707633 | K062412 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CRYOMATIC 85851646 4978331 Live/Registered |
Keeler Limited 2013-02-15 |
CRYOMATIC 73160892 1119580 Dead/Expired |
CHATTANOOGA PHARMACAL COMPANY 1978-03-06 |