Device Classification Name |
Light, Surgical, Instrument
|
510(k) Number |
K921848 |
Device Name |
BFW WEHMERLITE IV-A FIBER OPTIC SURG. HEADLIGHT |
Applicant |
ALM SURGICAL EQUIPMENT, INC. |
3323 WEST WARNER AVE. |
SANTA ANA,
CA
92704
|
|
Applicant Contact |
SUSAN NIELSEN |
Correspondent |
ALM SURGICAL EQUIPMENT, INC. |
3323 WEST WARNER AVE. |
SANTA ANA,
CA
92704
|
|
Correspondent Contact |
SUSAN NIELSEN |
Regulation Number | 878.4580
|
Classification Product Code |
|
Date Received | 04/17/1992 |
Decision Date | 10/01/1992 |
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
|