EBI DFS JOINT FIXATOR, MODEL 02800

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 Dfs Joint Fixator, Model 02800.

Pre-market Notification Details

Device IDK981483
510k NumberK981483
Device Name:EBI DFS JOINT FIXATOR, MODEL 02800
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Multiple Component
Applicant ELECTRO-BIOLOGY, INC. 6 UPPER POND RD. P.O. BOX 345 Parsippany,  NJ  07054
ContactJon Caparotta
CorrespondentJon Caparotta
ELECTRO-BIOLOGY, INC. 6 UPPER POND RD. P.O. BOX 345 Parsippany,  NJ  07054
Product CodeKTT  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-04-24
Decision Date1998-07-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00887868084461 K981483 000
00887868084430 K981483 000
00887868084423 K981483 000

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