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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Otoscope
510(k) Number K942244
Device Name REPLACEMENT BATTERIES/WELCH ALLYN #72200 POWER HANDLE
Applicant
National Custom Ent., Inc.
400 Gateway Blvd.
Burnsville,  MN  55337
Applicant Contact MICHAEL A BENYO
Correspondent
National Custom Ent., Inc.
400 Gateway Blvd.
Burnsville,  MN  55337
Correspondent Contact MICHAEL A BENYO
Regulation Number874.4770
Classification Product Code
ERA  
Date Received03/29/1994
Decision Date 06/24/1994
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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