DURALASTIC SHEETING

Elastomer, Silicone Block

APPLIED BIOMATERIAL TECHNOLOGIES

The following data is part of a premarket notification filed by Applied Biomaterial Technologies with the FDA for Duralastic Sheeting.

Pre-market Notification Details

Device IDK935571
510k NumberK935571
Device Name:DURALASTIC SHEETING
ClassificationElastomer, Silicone Block
Applicant APPLIED BIOMATERIAL TECHNOLOGIES 3500 N.W. ANDERSON HILL RD. SUITE #101 SILVERDALE,  WA  98383
ContactGERALD HANSON
CorrespondentGERALD HANSON
APPLIED BIOMATERIAL TECHNOLOGIES 3500 N.W. ANDERSON HILL RD. SUITE #101 SILVERDALE,  WA  98383
Product CodeMIB  
CFR Regulation Number874.3620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-11-18
Decision Date1995-01-31

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.