Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K932604 |
Device Name |
UNIGRIP-FH SURGICAL HANDPIECE/LAPAROSCOPIC |
Applicant |
UNISURGE, INC. |
10231 BUBB RD. |
CUPERTINO,
CA
95014
|
|
Applicant Contact |
DONALD V JOHNSON |
Correspondent |
UNISURGE, INC. |
10231 BUBB RD. |
CUPERTINO,
CA
95014
|
|
Correspondent Contact |
DONALD V JOHNSON |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 05/28/1993 |
Decision Date | 08/10/1993 |
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
|
|
|