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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 K992361
Device Name PALL SURGICLEAR LAPAROSCOPIC SMOKE FILTRATION SYSTEM, MODEL CLSF1
Applicant
Pall Medical
2200 Northern Blvd.
East Hills,  NY  11548 -1209
Applicant Contact LEONARD S BERMAN
Correspondent
Pall Medical
2200 Northern Blvd.
East Hills,  NY  11548 -1209
Correspondent Contact LEONARD S BERMAN
Regulation Number878.5070
Classification Product Code
FYD  
Date Received07/15/1999
Decision Date 08/20/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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