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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 K935439
Device Name SNJ SMOKE EVACUATION SUCTION WAND
Applicant
Lca, Inc.
1101 St. Gregory St.
Cincinnati,  OH  45202
Applicant Contact MICHAEL D JOHNSON
Correspondent
Lca, Inc.
1101 St. Gregory St.
Cincinnati,  OH  45202
Correspondent Contact MICHAEL D JOHNSON
Regulation Number878.5070
Classification Product Code
FYD  
Subsequent Product Code
GEX  
Date Received11/12/1993
Decision Date 03/07/1994
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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