BONE SCREW WASHER

Washer, Bolt Nut

ACUMED, INC.

The following data is part of a premarket notification filed by Acumed, Inc. with the FDA for Bone Screw Washer.

Pre-market Notification Details

Device IDK943782
510k NumberK943782
Device Name:BONE SCREW WASHER
ClassificationWasher, Bolt Nut
Applicant ACUMED, INC. 10950 S.W. 5TH ST. SUITE 170 Beaverton,  OR  97005
ContactShari L Jeffers
CorrespondentShari L Jeffers
ACUMED, INC. 10950 S.W. 5TH ST. SUITE 170 Beaverton,  OR  97005
Product CodeHTN  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-08-03
Decision Date1994-12-20

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