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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 K843617
Device Name SDC SILICONE SUMP DRAIN
Applicant
Science Development Corp.
6 Pearl Ct.
Allendale,  NJ  07401
Applicant Contact GEORGE E KING
Correspondent
Science Development Corp.
6 Pearl Ct.
Allendale,  NJ  07401
Correspondent Contact GEORGE E KING
Regulation Number878.4200
Classification Product Code
GBX  
Date Received09/14/1984
Decision Date 10/24/1984
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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