Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K932977 |
Device Name |
CABOT MEDICAL OPTIMA HAND INSTRUMENTS |
Applicant |
CABOT MEDICAL CORP. |
2021 CABOT BOULEVARD WEST |
LANGHORNE,
PA
19047
|
|
Applicant Contact |
TODD POLK |
Correspondent |
CABOT MEDICAL CORP. |
2021 CABOT BOULEVARD WEST |
LANGHORNE,
PA
19047
|
|
Correspondent Contact |
TODD POLK |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 06/17/1993 |
Decision Date | 09/07/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|