SHARPOINT LUKENS BONE WAX

Wax, Bone

SURGICAL SPECIALTIES CORP.

The following data is part of a premarket notification filed by Surgical Specialties Corp. with the FDA for Sharpoint Lukens Bone Wax.

Pre-market Notification Details

Device IDK050292
510k NumberK050292
Device Name:SHARPOINT LUKENS BONE WAX
ClassificationWax, Bone
Applicant SURGICAL SPECIALTIES CORP. 100 DENNIS DR. Reading,  PA  19606
ContactElizabeth Lazaro
CorrespondentElizabeth Lazaro
SURGICAL SPECIALTIES CORP. 100 DENNIS DR. Reading,  PA  19606
Product CodeMTJ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-02-07
Decision Date2005-03-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10848782008268 K050292 000
10848782005625 K050292 000
34026704635659 K050292 000

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