SAM JUNCTIONAL TOURNIQUET

Clamp, Vascular

SAM MEDICAL PRODUCTS

The following data is part of a premarket notification filed by Sam Medical Products with the FDA for Sam Junctional Tourniquet.

Pre-market Notification Details

Device IDK123694
510k NumberK123694
Device Name:SAM JUNCTIONAL TOURNIQUET
ClassificationClamp, Vascular
Applicant SAM MEDICAL PRODUCTS 27350 SW 95th Ave Ste 3038 Bldg 30 Wilsonville,  OR  97070
ContactJack N Mccutcheon
CorrespondentJack N Mccutcheon
SAM MEDICAL PRODUCTS 27350 SW 95th Ave Ste 3038 Bldg 30 Wilsonville,  OR  97070
Product CodeDXC  
CFR Regulation Number870.4450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-12-03
Decision Date2013-03-07
Summary:summary

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