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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 K951049
Device Name SPECULUM, ENT (S3)
Applicant
PEDIA PALS, INC.
3939 INTERNATIONAL GATEWAY
COLUMBUS,  OH  43219
Applicant Contact DAVID L BARNES
Correspondent
PEDIA PALS, INC.
3939 INTERNATIONAL GATEWAY
COLUMBUS,  OH  43219
Correspondent Contact DAVID L BARNES
Regulation Number874.4770
Classification Product Code
ERA  
Date Received03/06/1995
Decision Date 04/17/1995
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
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