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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 COURT
ALLENDALE,  NJ  07401 -
Applicant Contact GEORGE E KING
Correspondent
SCIENCE DEVELOPMENT CORP.
6 PEARL COURT
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
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