MODEL 668, TRACTION SPLINT, ADULT

Apparatus, Traction, Non-powered

FERNO-WASHINGTON, INC.

The following data is part of a premarket notification filed by Ferno-washington, Inc. with the FDA for Model 668, Traction Splint, Adult.

Pre-market Notification Details

Device IDK864765
510k NumberK864765
Device Name:MODEL 668, TRACTION SPLINT, ADULT
ClassificationApparatus, Traction, Non-powered
Applicant FERNO-WASHINGTON, INC. 70 WEIL WAY Wilmington,  OH  45177
ContactEric N Besanko
CorrespondentEric N Besanko
FERNO-WASHINGTON, INC. 70 WEIL WAY Wilmington,  OH  45177
Product CodeHST  
CFR Regulation Number888.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-12-05
Decision Date1986-12-17

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