Device Classification Name |
laparoscope, general & plastic surgery
|
510(k) Number |
K923945 |
Device Name |
PLEATMAN SAC SPECIMEN CONTAINER |
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 | 876.1500
|
Classification Product Code |
|
Date Received | 08/04/1992 |
Decision Date | 02/05/1993 |
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
|
Recalls |
CDRH Recalls
|