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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 K921424
Device Name SIL-MED FLAT SUCTION DRAIN
Applicant
Sil-Med Corp.
700 Warner Blvd.
Taunton,  MA  02780
Applicant Contact LOURDES V CONCEPCIO
Correspondent
Sil-Med Corp.
700 Warner Blvd.
Taunton,  MA  02780
Correspondent Contact LOURDES V CONCEPCIO
Regulation Number878.4200
Classification Product Code
GBX  
Date Received03/24/1992
Decision Date 09/28/1992
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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