FLEXISCOPE II ARTHROSCOPES AND ACCESSORIES


Device Classification Name

arthroscope

510(k) Number K992040
Device Name FLEXISCOPE II ARTHROSCOPES AND ACCESSORIES
Applicant
FIBER IMAGING TECHNOLOGIES, INC.
45 pontiac rd.
newton, 
MA 
02468

Applicant Contact joseph ress
Correspondent
FIBER IMAGING TECHNOLOGIES, INC.
45 pontiac rd.
newton, 
MA 
02468

Correspodent Contact joseph ress
Regulation Number 888.1100
Classification Product Code
HRX  
Date Received 06/17/1999
Decision Date 08/06/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

General & Plastic Surgery

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No