Device Classification Name |
Gown, Surgical
|
510(k) Number |
K910515 |
Device Name |
FREEDOM MARK III SURGICAL HELMET SYSTEM |
Applicant |
STACKHOUSE ASSOC. |
2059 ATLANTA AVE. |
RIVERSIDE,
CA
92507
|
|
Applicant Contact |
GREEN, JR. |
Correspondent |
STACKHOUSE ASSOC. |
2059 ATLANTA AVE. |
RIVERSIDE,
CA
92507
|
|
Correspondent Contact |
GREEN, JR. |
Regulation Number | 878.4040
|
Classification Product Code |
|
Date Received | 02/05/1991 |
Decision Date | 05/06/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|