MICROTABLE SYSTEM

Neurological Stereotaxic Instrument

FRED HAER COMPANY, INC.

The following data is part of a premarket notification filed by Fred Haer Company, Inc. with the FDA for Microtable System.

Pre-market Notification Details

Device IDK132611
510k NumberK132611
Device Name:MICROTABLE SYSTEM
ClassificationNeurological Stereotaxic Instrument
Applicant FRED HAER COMPANY, INC. 1201 MAIN STREET Bowdoin,  ME  04287
ContactKeri Seitz
CorrespondentKeri Seitz
FRED HAER COMPANY, INC. 1201 MAIN STREET Bowdoin,  ME  04287
Product CodeHAW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-08-20
Decision Date2014-03-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00873263006436 K132611 000
10873263006457 K132611 000
10873263006440 K132611 000
00196852534531 K132611 000

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