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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K935495
Device Name PF404/409/410/411/416/418 W/PF319:0/319:1/319:2
Applicant
Perimed, Inc.
200 Centennial Ave.
Piscataway,  NJ  08854
Applicant Contact OYSTEIN LIND
Correspondent
Perimed, Inc.
200 Centennial Ave.
Piscataway,  NJ  08854
Correspondent Contact OYSTEIN LIND
Regulation Number878.4810
Classification Product Code
GEX  
Date Received11/15/1993
Decision Date 04/18/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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