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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 K926495
Device Name SIL-SLIP ROUND WOUND DRAIN (COATED)/BLUE STRIPE
Applicant
SIL-MED CORP.
700 WARNER BLVD.
TAUNTON,  MA  02780
Applicant Contact V CONCEPCION
Correspondent
SIL-MED CORP.
700 WARNER BLVD.
TAUNTON,  MA  02780
Correspondent Contact V CONCEPCION
Regulation Number878.4200
Classification Product Code
GBX  
Date Received12/29/1992
Decision Date 02/02/1994
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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