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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 K961295
Device Name SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCAR
Applicant
SIL-MED CORP.
700 WARNER BLVD.
TAUNTON,  MA  02780
Applicant Contact KAREN K SYLVIA
Correspondent
SIL-MED CORP.
700 WARNER BLVD.
TAUNTON,  MA  02780
Correspondent Contact KAREN K SYLVIA
Regulation Number878.4200
Classification Product Code
GBX  
Date Received04/04/1996
Decision Date 06/26/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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