PMT NEW BEGINNINGS GELSHAPES & AMEND

Elastomer, Silicone, For Scar Management

PMT CORP.

The following data is part of a premarket notification filed by Pmt Corp. with the FDA for Pmt New Beginnings Gelshapes & Amend.

Pre-market Notification Details

Device IDK972597
510k NumberK972597
Device Name:PMT NEW BEGINNINGS GELSHAPES & AMEND
ClassificationElastomer, Silicone, For Scar Management
Applicant PMT CORP. 1500 PARK RD. Chanhassen,  MN  55317
ContactStephen M Trinter
CorrespondentStephen M Trinter
PMT CORP. 1500 PARK RD. Chanhassen,  MN  55317
Product CodeMDA  
CFR Regulation Number878.4025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-07-11
Decision Date1997-10-01
Summary:summary

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