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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve
510(k) Number K945242
Device Name NERVE MONITOR ELECTRODES/STIMULATOR PROBES
Applicant
Micromed Development Corp.
4911 Creekside Dr.
Clearwater,  FL  34620
Applicant Contact DAN H TRECE
Correspondent
Micromed Development Corp.
4911 Creekside Dr.
Clearwater,  FL  34620
Correspondent Contact DAN H TRECE
Regulation Number874.1820
Classification Product Code
ETN  
Date Received10/27/1994
Decision Date 12/27/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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