| Device Classification Name |
electrocautery, gynecologic (and accessories)
|
|---|
| 510(k) Number |
K923570 |
|---|
| Device Name |
CRYOMEDICS LLETZ LOOPS |
|---|
| Applicant |
| CABOT MEDICAL CORP. |
| 2021 CABOT BOULEVARD WEST |
|
LANGHORNE,
PA
19047
|
|
| Applicant Contact |
TODD J POLK |
| Correspondent |
| CABOT MEDICAL CORP. |
| 2021 CABOT BOULEVARD WEST |
|
LANGHORNE,
PA
19047
|
|
| Correspondent Contact |
TODD J POLK |
| Regulation Number | 884.4120
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 07/17/1992 |
|---|
| Decision Date | 02/28/1994 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Obstetrics/Gynecology
|
|---|
| 510k Review Panel |
Obstetrics/Gynecology
|
|---|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|