J-SCOPE SYSTEM


Device Classification Name

arthroscope

510(k) Number K122411
Device Name J-SCOPE SYSTEM
Applicant
MYELOTEC
2600 mullinix mill road
mt. airy, 
MD 
21771

Applicant Contact blix winston
Correspondent
MYELOTEC
2600 mullinix mill road
mt. airy, 
MD 
21771

Correspodent Contact blix winston
Regulation Number 888.1100
Classification Product Code
HRX  
Date Received 08/08/2012
Decision Date 02/11/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

General & Plastic Surgery

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No