SHEAUMANN PL-980


Device Classification Name

powered laser surgical instrument

510(k) Number K111360
Device Name SHEAUMANN PL-980
Applicant
SHEAUMANN LASERS
189 winding oaks lane
oviedo, 
FL 
32765

Applicant Contact timothy j shea
Correspondent
SHEAUMANN LASERS
189 winding oaks lane
oviedo, 
FL 
32765

Correspodent Contact timothy j shea
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 05/16/2011
Decision Date 09/14/2011
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