STRATO PORT INTRODUCER KT(10 FR) LPS 5057/MODIFIED

Port & Catheter, Implanted, Subcutaneous, Intravascular

STRATO MEDICAL CORP.

The following data is part of a premarket notification filed by Strato Medical Corp. with the FDA for Strato Port Introducer Kt(10 Fr) Lps 5057/modified.

Pre-market Notification Details

Device IDK905840
510k NumberK905840
Device Name:STRATO PORT INTRODUCER KT(10 FR) LPS 5057/MODIFIED
ClassificationPort & Catheter, Implanted, Subcutaneous, Intravascular
Applicant STRATO MEDICAL CORP. 123 BRIMBAL AVE. P.O.B.3148 Beverly,  MA  01915
ContactNancy C Hall
CorrespondentNancy C Hall
STRATO MEDICAL CORP. 123 BRIMBAL AVE. P.O.B.3148 Beverly,  MA  01915
Product CodeLJT  
CFR Regulation Number880.5965 [🔎]
DecisionSubstantially Equivalent - Kit (SESK)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-12-27
Decision Date1991-04-19

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