Device Classification Name |
Kit, Surgical Instrument, Disposable
|
510(k) Number |
K910816 |
Device Name |
IN-SIGHT SURGICAL INSTRUMENT KITS, DISPOSABLE |
Applicant |
INSIGHT INTERNATIONAL, INC. |
500 PROSPECT ST. |
PAWTUCKET,
RI
02860
|
|
Applicant Contact |
PHILLIP F JANES |
Correspondent |
INSIGHT INTERNATIONAL, INC. |
500 PROSPECT ST. |
PAWTUCKET,
RI
02860
|
|
Correspondent Contact |
PHILLIP F JANES |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 02/26/1991 |
Decision Date | 04/17/1991 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|