ACROMED WALLIE-HEINIG OSTEOTOMES

Osteotome

BUCKMAN CO., INC.

The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for Acromed Wallie-heinig Osteotomes.

Pre-market Notification Details

Device IDK870780
510k NumberK870780
Device Name:ACROMED WALLIE-HEINIG OSTEOTOMES
ClassificationOsteotome
Applicant BUCKMAN CO., INC. 921 CALLE VERDE Martinez,  CA  94553
ContactDavid W Schlerf
CorrespondentDavid W Schlerf
BUCKMAN CO., INC. 921 CALLE VERDE Martinez,  CA  94553
Product CodeHWM  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-02-26
Decision Date1987-03-09

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