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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tray, Surgical, Instrument
510(k) Number K842009
Device Name ABDOMINAL PARACENTESIS TRAY
Applicant
Jayco Pharmaceuticals
895 Poplar Church Rd.
Camp Hill,  PA  17011
Applicant Contact LESTER J LIFTON
Correspondent
Jayco Pharmaceuticals
895 Poplar Church Rd.
Camp Hill,  PA  17011
Correspondent Contact LESTER J LIFTON
Regulation Number878.4800
Classification Product Code
FSM  
Date Received05/17/1984
Decision Date 10/23/1984
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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