Device Classification Name |
Scalpel, One-Piece
|
510(k) Number |
K923689 |
Device Name |
SURGISTAR BLADES |
Applicant |
SURGISTAR, INC. |
P.O. BOX 2722 |
VISTA,
CA
92085
|
|
Applicant Contact |
JONATHAN WOODWARD |
Correspondent |
SURGISTAR, INC. |
P.O. BOX 2722 |
VISTA,
CA
92085
|
|
Correspondent Contact |
JONATHAN WOODWARD |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 07/24/1992 |
Decision Date | 09/09/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|