AOC BONE WAX

Wax, Bone

CEREMED INC.

The following data is part of a premarket notification filed by Ceremed Inc. with the FDA for Aoc Bone Wax.

Pre-market Notification Details

Device IDK041363
510k NumberK041363
Device Name:AOC BONE WAX
ClassificationWax, Bone
Applicant CEREMED INC. 3643 LENAWEE AVE. Los Angeles,  CA  90016
ContactTadeusz Wekkusz Md
CorrespondentTadeusz Wekkusz Md
CEREMED INC. 3643 LENAWEE AVE. Los Angeles,  CA  90016
Product CodeMTJ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-05-21
Decision Date2004-07-27
Summary:summary

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