SUTRALENE POLYPROPYLENE SUTURES

Suture, Nonabsorbable, Synthetic, Polypropylene

VISIONARY MEDICAL SUPPLIES, INC.

The following data is part of a premarket notification filed by Visionary Medical Supplies, Inc. with the FDA for Sutralene Polypropylene Sutures.

Pre-market Notification Details

Device IDK070243
510k NumberK070243
Device Name:SUTRALENE POLYPROPYLENE SUTURES
ClassificationSuture, Nonabsorbable, Synthetic, Polypropylene
Applicant VISIONARY MEDICAL SUPPLIES, INC. 800 LEVANGER LN. Stoughton,  WI  53589
ContactGary Syring
CorrespondentGary Syring
VISIONARY MEDICAL SUPPLIES, INC. 800 LEVANGER LN. Stoughton,  WI  53589
Product CodeGAW  
CFR Regulation Number878.5010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-01-25
Decision Date2007-04-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M583P990623 K070243 000
M583P90090623 K070243 000
M583P9006223 K070243 000
M583P900623 K070243 000
M583P90060623 K070243 000
M583P540151RC3 K070243 000
M583P109062TP3 K070243 000
M583P1000623 K070243 000

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