Device Classification Name |
unit, cryosurgical, accessories
|
510(k) Number |
K922878 |
Device Name |
MODEL GT1ST CRYOSURGICAL INSTRUMENT |
Applicant |
GYNE-TECH INSTRUMENT CORP. |
1111 CHESTNUT ST. |
BURBANK,
CA
91506
|
|
Applicant Contact |
KERMIT FLOYD |
Correspondent |
GYNE-TECH INSTRUMENT CORP. |
1111 CHESTNUT ST. |
BURBANK,
CA
91506
|
|
Correspondent Contact |
KERMIT FLOYD |
Regulation Number | 878.4350
|
Classification Product Code |
|
Date Received | 06/15/1992 |
Decision Date | 09/02/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|