Device Classification Name |
light, surgical, accessories
|
510(k) Number |
K915068 |
Device Name |
PLASTIC DISPOSABLE SURGICAL LIGHT HANDLE COVER |
Applicant |
AMERICAN MEDICAL MFG., INC. |
22231 MULHOLLAND HWY. |
CALABASAS,
CA
91302
|
|
Applicant Contact |
MIKE HOFTMAN |
Correspondent |
AMERICAN MEDICAL MFG., INC. |
22231 MULHOLLAND HWY. |
CALABASAS,
CA
91302
|
|
Correspondent Contact |
MIKE HOFTMAN |
Regulation Number | 878.4580
|
Classification Product Code |
|
Date Received | 11/08/1991 |
Decision Date | 02/06/1992 |
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
|