ANSPACH MICROMAX SYSTEM

Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece

THE ANSPACH EFFORT, INC.

The following data is part of a premarket notification filed by The Anspach Effort, Inc. with the FDA for Anspach Micromax System.

Pre-market Notification Details

Device IDK965080
510k NumberK965080
Device Name:ANSPACH MICROMAX SYSTEM
ClassificationDrill, Surgical, Ent (electric Or Pneumatic) Including Handpiece
Applicant THE ANSPACH EFFORT, INC. 4500 RIVERSIDE DR. Palm Beach Gardens,  FL  33410
ContactWilliam E Anspach, Iii M.d.
CorrespondentWilliam E Anspach, Iii M.d.
THE ANSPACH EFFORT, INC. 4500 RIVERSIDE DR. Palm Beach Gardens,  FL  33410
Product CodeERL  
CFR Regulation Number874.4250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-12-19
Decision Date1997-01-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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