FAST SET PUTTY

Methyl Methacrylate For Cranioplasty

SYNTHES (USA)

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

Pre-market Notification Details

Device IDK012589
510k NumberK012589
Device Name:FAST SET PUTTY
ClassificationMethyl Methacrylate For Cranioplasty
Applicant SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
ContactThomas M Maguire
CorrespondentThomas M Maguire
SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
Product CodeGXP  
CFR Regulation Number882.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-08-10
Decision Date2002-02-07
Summary:summary

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