SHARPLAN LASERS, INC. SILKTOUCH FLASH SCANNER


Device Classification Name

powered laser surgical instrument

510(k) Number K960521
Device Name SHARPLAN LASERS, INC. SILKTOUCH FLASH SCANNER
Applicant
SHARPLAN LASERS, INC.
one pearl ct.
allendale, 
NJ 
07401

Applicant Contact george j hattub
Correspondent
SHARPLAN LASERS, INC.
one pearl ct.
allendale, 
NJ 
07401

Correspodent Contact george j hattub
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 02/05/1996
Decision Date 04/26/1996
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No