Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K933330 |
Device Name |
AESCULAP MANUAL ENDOSCOPIC INSTRUMENTS |
Applicant |
AESCULAP, INC. |
1000 GATEWAY BLVD. |
SOUTH SAN FRANCISCO,
CA
94080
|
|
Applicant Contact |
VICTORIA MACKINNON |
Correspondent |
AESCULAP, INC. |
1000 GATEWAY BLVD. |
SOUTH SAN FRANCISCO,
CA
94080
|
|
Correspondent Contact |
VICTORIA MACKINNON |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 07/08/1993 |
Decision Date | 06/07/1994 |
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
|
|
|