NORIAN SRS FAST SET PUTTY

Filler, Bone Void, Calcium Compound

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Norian Srs Fast Set Putty.

Pre-market Notification Details

Device IDK041842
510k NumberK041842
Device Name:NORIAN SRS FAST SET PUTTY
ClassificationFiller, Bone Void, Calcium Compound
Applicant SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
ContactSheri L Musgnung
CorrespondentSheri L Musgnung
SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
Product CodeMQV  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-07-08
Decision Date2004-07-23
Summary:summary

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