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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Exhaust, Surgical
510(k) Number K912853
Device Name PLP EVACUATION CONTROL SYSTEM 1 MICRO (ECS.1UM)
Applicant
Precision Laser Products, Inc.
2950-N Advance Ln.
Colmar,  PA  18915
Applicant Contact PERK CROOK
Correspondent
Precision Laser Products, Inc.
2950-N Advance Ln.
Colmar,  PA  18915
Correspondent Contact PERK CROOK
Regulation Number878.5070
Classification Product Code
FYD  
Date Received06/28/1991
Decision Date 08/20/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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