Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K061690
Device Classification Name
Light, Surgical, Fiberoptic
More FDA Info for this Device
510(K) Number
K061690
Device Name
Light, Surgical, Fiberoptic
Applicant
GULF MEDICAL FIBEROPTICS
148 DUNBAR AVE., UNIT B
OLDSMAR, FL 34677 US
Other 510(k) Applications for this Company
Contact
MARCELINO AFANADOR
Other 510(k) Applications for this Contact
Regulation Number
878.4580
More FDA Info for this Regulation Number
Classification Product Code
FST
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/15/2006
Decision Date
09/15/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact