Device Classification Name |
brush, scrub, operating-room
|
510(k) Number |
K844411 |
Device Name |
SCRUB MATE DRY STERILE SCRUB BRUSH |
Applicant |
AMERICAN STERILIZER CO. |
2424 WEST 23RD ST. |
P.O. BOX 620 |
ERIE,
PA
16514
|
|
Applicant Contact |
JAMES A SPALLINA |
Correspondent |
AMERICAN STERILIZER CO. |
2424 WEST 23RD ST. |
P.O. BOX 620 |
ERIE,
PA
16514
|
|
Correspondent Contact |
JAMES A SPALLINA |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 11/14/1984 |
Decision Date | 12/17/1984 |
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
|