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 |