ENDOSCOPIC FIBEROPTIC CABLE


Device Classification Name

illuminator, fiberoptic, surgical field

510(k) Number K021931
Device Name ENDOSCOPIC FIBEROPTIC CABLE
Original Applicant
GULF MEDICAL FIBEROPTICS
376 douglas rd.
unit d
oldsmar, 
FL 
34677

Original Contact marcelino afanador
Regulation Number 878.4580
Classification Product Code
HBI  
Subsequent Product Code
FFS  
Date Received 06/12/2002
Decision Date 09/06/2002
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