Device Classification Name |
Light, Surgical, Fiberoptic
|
510(k) Number |
K991572 |
Device Name |
ISOLUX SURGICAL HEADLIGHT |
Applicant |
ISOLUX AMERICA |
1479 RAILHEAD BLVD. |
NAPLES,
FL
34110 -8444
|
|
Applicant Contact |
STUART L MCGHEE |
Correspondent |
ISOLUX AMERICA |
1479 RAILHEAD BLVD. |
NAPLES,
FL
34110 -8444
|
|
Correspondent Contact |
STUART L MCGHEE |
Regulation Number | 878.4580
|
Classification Product Code |
|
Date Received | 05/05/1999 |
Decision Date | 07/08/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|