ARMAND ENDOSCOPE HOLDER


Device Classification Name

laparoscope, general & plastic surgery

510(k) Number K050051
Device Name ARMAND ENDOSCOPE HOLDER
Applicant
KLS-MARTIN L.P.
11239-1 st. john’s ind. pkwy.
south
jacksonville, 
FL 
32246

Applicant Contact jennifer damato
Correspondent
KLS-MARTIN L.P.
11239-1 st. john’s ind. pkwy.
south
jacksonville, 
FL 
32246

Correspodent Contact jennifer damato
Regulation Number 876.1500
Classification Product Code
GCJ  
Date Received 01/10/2005
Decision Date 05/16/2005
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No