DANMAR PRODUCTS CRANIAL ADJUSTIVE PROSTHESIS

Orthosis, Cranial

DANMAR PRODUCTS, INC.

The following data is part of a premarket notification filed by Danmar Products, Inc. with the FDA for Danmar Products Cranial Adjustive Prosthesis.

Pre-market Notification Details

Device IDK013452
510k NumberK013452
Device Name:DANMAR PRODUCTS CRANIAL ADJUSTIVE PROSTHESIS
ClassificationOrthosis, Cranial
Applicant DANMAR PRODUCTS, INC. 221 JACKSON INDUSTRIAL DR. Ann Arbor,  MI  48103
ContactKaren A Lindner
CorrespondentKaren A Lindner
DANMAR PRODUCTS, INC. 221 JACKSON INDUSTRIAL DR. Ann Arbor,  MI  48103
Product CodeMVA  
CFR Regulation Number882.5970 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-10-18
Decision Date2003-10-31
Summary:summary

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