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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical Device
510(k) Number K942823
FOIA Releasable 510(k) K942823
Device Name MAHE INSTRUMENTS
Applicant
Mahe Intl., Inc.
300 James Robertson Pkwy.
Nashville,  TN  37201
Applicant Contact WINFRIED REICH
Correspondent
Mahe Intl., Inc.
300 James Robertson Pkwy.
Nashville,  TN  37201
Correspondent Contact WINFRIED REICH
Regulation Number878.4400
Classification Product Code
DWG  
Date Received06/14/1994
Decision Date 12/05/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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