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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
510(k) Number K943108
Device Name MEDNEXT MICRO-DRILL
Applicant
Mednext, Inc.
2000 Ave. "P", Suite 8
Riviera Beach,  FL  33404
Applicant Contact THOMAS J MICKEL, PH.D.
Correspondent
Mednext, Inc.
2000 Ave. "P", Suite 8
Riviera Beach,  FL  33404
Correspondent Contact THOMAS J MICKEL, PH.D.
Regulation Number874.4250
Classification Product Code
ERL  
Date Received06/29/1994
Decision Date 08/17/1994
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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