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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 K911650
Device Name PEDIA PALS
Applicant
Pedia Pals, Inc.
P.O. Box 21934
1964 Collingwood Rd.
Columbus,  OH  43221
Applicant Contact HANSEL, JR.
Correspondent
Pedia Pals, Inc.
P.O. Box 21934
1964 Collingwood Rd.
Columbus,  OH  43221
Correspondent Contact HANSEL, JR.
Regulation Number874.4770
Classification Product Code
ERA  
Date Received04/12/1991
Decision Date 10/17/1991
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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