CryoLab
Unit, Cryosurgical, Accessories
CryoConcepts LP
The following data is part of a premarket notification filed by Cryoconcepts Lp with the FDA for Cryolab.
Pre-market Notification Details
| Device ID | K190407 |
| 510k Number | K190407 |
| Device Name: | CryoLab |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | CryoConcepts LP 205 Webster St Bethlehem, PA 18015 |
| Contact | Sam Niedbala |
| Correspondent | Sam Niedbala CryoConcepts LP 205 Webster St Bethlehem, PA 18015 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-21 |
| Decision Date | 2019-04-22 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850077006074 | K190407 | 000 |
| 00850077006067 | K190407 | 000 |
Trademark Results [CryoLab]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CRYOLAB 87691014 5625573 Live/Registered |
CryoConcepts LP 2017-11-20 |
 CRYOLAB 74143700 not registered Dead/Abandoned |
Saes Pure Gas, Inc. 1991-03-01 |
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