CRYOMEGA
Unit, Cryosurgical, Accessories
STC CONSULTING LLC
The following data is part of a premarket notification filed by Stc Consulting Llc with the FDA for Cryomega.
Pre-market Notification Details
| Device ID | K102006 |
| 510k Number | K102006 |
| Device Name: | CRYOMEGA |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | STC CONSULTING LLC 4093 MAULFAIR DRIVE Allentown, PA 18103 |
| Contact | R. Sam Niedbala |
| Correspondent | R. Sam Niedbala STC CONSULTING LLC 4093 MAULFAIR DRIVE Allentown, PA 18103 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-16 |
| Decision Date | 2010-10-06 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00192896009349 | K102006 | 000 |
| 00192896009332 | K102006 | 000 |
| 00850077006050 | K102006 | 000 |
| 00850077006043 | K102006 | 000 |
| 10850077006033 | K102006 | 000 |
| 00850077006029 | K102006 | 000 |
| 00850077006012 | K102006 | 000 |
| 10850077006002 | K102006 | 000 |
| 00850077006210 | K102006 | 000 |
Trademark Results [CRYOMEGA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CRYOMEGA 86412870 4847528 Live/Registered |
CryoConcepts LP 2014-10-02 |
 CRYOMEGA 85099719 3979568 Live/Registered |
CRYOCONCEPTS LP 2010-08-04 |
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