ASCENSION SILLICONE MCP

Prosthesis, Finger, Constrained, Polymer

ASCENSION ORTHOPEDICS, INC.

The following data is part of a premarket notification filed by Ascension Orthopedics, Inc. with the FDA for Ascension Sillicone Mcp.

Pre-market Notification Details

Device IDK022892
510k NumberK022892
Device Name:ASCENSION SILLICONE MCP
ClassificationProsthesis, Finger, Constrained, Polymer
Applicant ASCENSION ORTHOPEDICS, INC. 8200 CAMERON RD., SUITE C-140 Austin,  TX  78754 -3832
ContactRobert M Wolfarth
CorrespondentRobert M Wolfarth
ASCENSION ORTHOPEDICS, INC. 8200 CAMERON RD., SUITE C-140 Austin,  TX  78754 -3832
Product CodeKYJ  
CFR Regulation Number888.3230 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-08-30
Decision Date2002-11-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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10381780114383 K022892 000

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