MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS

Holder, Head, Neurosurgical (skull Clamp)

INTEGRA LIFESCIENCES CORPORATION

The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Mayfield Radiolucent Disposable Skull Pins.

Pre-market Notification Details

Device IDK071458
510k NumberK071458
Device Name:MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS
ClassificationHolder, Head, Neurosurgical (skull Clamp)
Applicant INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. Plainsboro,  NJ  08536
ContactDonna Wallace
CorrespondentDonna Wallace
INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. Plainsboro,  NJ  08536
Product CodeHBL  
CFR Regulation Number882.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-05-25
Decision Date2007-06-13
Summary:summary

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