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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drain, Cervical
510(k) Number K903989
Device Name SIL-MED T-TUBE DRAIN
Applicant
Sil-Med Corp.
700 Warner Blvd.
Taunton,  MA  02780
Applicant Contact WILLIAM S MCCALLUM
Correspondent
Sil-Med Corp.
700 Warner Blvd.
Taunton,  MA  02780
Correspondent Contact WILLIAM S MCCALLUM
Regulation Number884.3200
Classification Product Code
HFL  
Date Received08/29/1990
Decision Date 01/31/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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