RESORBABLE CRANIAL CLAMPS

Cover, Burr Hole

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Resorbable Cranial Clamps.

Pre-market Notification Details

Device IDK021408
510k NumberK021408
Device Name:RESORBABLE CRANIAL CLAMPS
ClassificationCover, Burr Hole
Applicant SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
ContactMatthew M Hull
CorrespondentMatthew M Hull
SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
Product CodeGXR  
CFR Regulation Number882.5250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-05-03
Decision Date2002-07-29
Summary:summary

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