Device Classification Name |
Forceps, Biopsy, Electric, Reprocessed
|
510(k) Number |
K024011 |
Device Name |
SISS REPROCESSED HOT BIOPSY FORCEPS, LAPAROSCOPIC, ENDOSCOPIC AND ELECTROSURGICAL SURGICAL INSTRUMENTS AND ACCESSORIES |
Applicant |
SURGICAL INSTRUMENTS SERVICE AND SAVINGS, INC. |
723 CURTIS CT; PO BOX 2060 |
SISTERS,
OR
97759
|
|
Applicant Contact |
MARY ANN BARKER |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
2600 NW LAKE RD. |
CAMAS,
WA
98607 -9526
|
|
Correspondent Contact |
ROBERT M BOONSTRA |
Regulation Number | 876.4300
|
Classification Product Code |
|
Date Received | 12/04/2002 |
Decision Date | 12/19/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|