ERGOMED
Unit, Cryosurgical, Accessories
KRYODERM USA, INC.
The following data is part of a premarket notification filed by Kryoderm Usa, Inc. with the FDA for Ergomed.
Pre-market Notification Details
| Device ID | K912529 |
| 510k Number | K912529 |
| Device Name: | ERGOMED |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | KRYODERM USA, INC. 2189 CLEVELAND ST. Clearwater, FL 34625 |
| Contact | Einwachter |
| Correspondent | Einwachter KRYODERM USA, INC. 2189 CLEVELAND ST. Clearwater, FL 34625 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-07 |
| Decision Date | 1994-04-26 |
Trademark Results [ERGOMED]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ERGOMED 79208081 5409607 Live/Registered |
ERGOMED ISTRAZIVANJA ZAGREB d.o.o. 2017-02-01 |
 ERGOMED 77812662 3820688 Dead/Cancelled |
Omega Health Systems, Inc. 2009-08-25 |
 ERGOMED 74390024 not registered Dead/Abandoned |
Ergomed Incorporated 1993-05-13 |
 ERGOMED 74281702 1812844 Dead/Cancelled |
Ergomed, Inc. 1992-06-05 |
 ERGOMED 73701294 1499467 Live/Registered |
KEIPER RECARO GMBH & CO. 1987-12-16 |
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