IMBIBE BONE MARROW ASPIRATION SYRINGE

Syringe, Piston

ORTHOVITA, INC.

The following data is part of a premarket notification filed by Orthovita, Inc. with the FDA for Imbibe Bone Marrow Aspiration Syringe.

Pre-market Notification Details

Device IDK023074
510k NumberK023074
Device Name:IMBIBE BONE MARROW ASPIRATION SYRINGE
ClassificationSyringe, Piston
Applicant ORTHOVITA, INC. 45 GREAT VALLEY PKWY. Malvern,  PA  19355
ContactAndreina Ide
CorrespondentAndreina Ide
ORTHOVITA, INC. 45 GREAT VALLEY PKWY. Malvern,  PA  19355
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-09-16
Decision Date2003-03-11
Summary:summary

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