Device Classification Name |
Light, Surgical, Fiberoptic
|
510(k) Number |
K061690 |
Device Name |
SURGICAL HEADLIGHT |
Applicant |
GULF MEDICAL FIBEROPTICS |
148 DUNBAR AVE., UNIT B |
OLDSMAR,
FL
34677
|
|
Applicant Contact |
MARCELINO AFANADOR |
Correspondent |
GULF MEDICAL FIBEROPTICS |
148 DUNBAR AVE., UNIT B |
OLDSMAR,
FL
34677
|
|
Correspondent Contact |
MARCELINO AFANADOR |
Regulation Number | 878.4580
|
Classification Product Code |
|
Date Received | 06/15/2006 |
Decision Date | 09/15/2006 |
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
|
Recalls |
CDRH Recalls
|
|
|