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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Irrigation
510(k) Number K870704
Device Name CLOSED PARACENTESIS SYSTEM W/BOASBERG CATHETER SET
Applicant
American Pharmaseal Div. Ahsc
27200 N. Tourney Rd.
Post Office Box 5900
Valencia,  CA  91355
Applicant Contact LAWRENCE W GETLIN
Correspondent
American Pharmaseal Div. Ahsc
27200 N. Tourney Rd.
Post Office Box 5900
Valencia,  CA  91355
Correspondent Contact LAWRENCE W GETLIN
Regulation Number878.4200
Classification Product Code
GBX  
Date Received02/20/1987
Decision Date 03/27/1987
Decision Substantially Equivalent - With Drug (SESD)
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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