SIL-SLIP (COATED/REGULAR(NON-COATED)THORACIC DRAIN

Catheter, Irrigation

SIL-MED CORP.

The following data is part of a premarket notification filed by Sil-med Corp. with the FDA for Sil-slip (coated/regular(non-coated)thoracic Drain.

Pre-market Notification Details

Device IDK926496
510k NumberK926496
Device Name:SIL-SLIP (COATED/REGULAR(NON-COATED)THORACIC DRAIN
ClassificationCatheter, Irrigation
Applicant SIL-MED CORP. 700 WARNER BLVD. Taunton,  MA  02780
ContactKaren K Sylvia
CorrespondentKaren K Sylvia
SIL-MED CORP. 700 WARNER BLVD. Taunton,  MA  02780
Product CodeGBX  
CFR Regulation Number878.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-12-29
Decision Date1995-05-24

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