Device Classification Name |
Tray, Surgical, Instrument
|
510(k) Number |
K844286 |
Device Name |
FLASH GUARD PLASTIC VERSION |
Applicant |
SPARCO, INC. |
P.O. BOX 20369 |
CASTRO VALLEY,
CA
94546
|
|
Applicant Contact |
BEVERLY J SPARKS |
Correspondent |
SPARCO, INC. |
P.O. BOX 20369 |
CASTRO VALLEY,
CA
94546
|
|
Correspondent Contact |
BEVERLY J SPARKS |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 11/05/1984 |
Decision Date | 11/19/1984 |
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
|