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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Urological, Disposable
510(k) Number K851675
Device Name THE PERCUTANEOUS NEPHROSTOLITHOTOMY DRAPE
Applicant
Lingeman Medical Products, Inc.
3401 Xenia Cir.
Indianapolis,  IN  46227
Applicant Contact PAUL LINGEMAN
Correspondent
Lingeman Medical Products, Inc.
3401 Xenia Cir.
Indianapolis,  IN  46227
Correspondent Contact PAUL LINGEMAN
Regulation Number878.4370
Classification Product Code
EYY  
Date Received04/23/1985
Decision Date 05/14/1985
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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