EBI SMALL EXTERNAL FIXATOR (S/E/F/)

Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

ELECTRO-BIOLOGY, INC.

The following data is part of a premarket notification filed by Electro-biology, Inc. with the FDA for Ebi Small External Fixator (s/e/f/).

Pre-market Notification Details

Device IDK951357
510k NumberK951357
Device Name:EBI SMALL EXTERNAL FIXATOR (S/E/F/)
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Multiple Component
Applicant ELECTRO-BIOLOGY, INC. 6 UPPER POND RD. P.O. BOX 345 Parsippany,  NJ  07054
ContactDan L Page
CorrespondentDan L Page
ELECTRO-BIOLOGY, INC. 6 UPPER POND RD. P.O. BOX 345 Parsippany,  NJ  07054
Product CodeKTT  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-03-24
Decision Date1995-06-21

NIH GUDID Devices

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