MICRO-AIRE STERNUM SAW REPLACEMENT BLADES

Blade, Saw, Surgical, Cardiovascular

MICRO-AIRE SURGICAL INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Micro-aire Surgical Instruments, Inc. with the FDA for Micro-aire Sternum Saw Replacement Blades.

Pre-market Notification Details

Device IDK850483
510k NumberK850483
Device Name:MICRO-AIRE STERNUM SAW REPLACEMENT BLADES
ClassificationBlade, Saw, Surgical, Cardiovascular
Applicant MICRO-AIRE SURGICAL INSTRUMENTS, INC. 505 FOURTH ST. San Fernando,  CA  91340
ContactGerald Brooks
CorrespondentGerald Brooks
MICRO-AIRE SURGICAL INSTRUMENTS, INC. 505 FOURTH ST. San Fernando,  CA  91340
Product CodeDWH  
CFR Regulation Number878.4820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-02-07
Decision Date1985-03-01

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