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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Speculum, Ent
510(k) Number K950086
Device Name PEDIA PALS, INCORPORATED
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 Number878.1800
Classification Product Code
EPY  
Subsequent Product Code
ERA  
Date Received01/10/1995
Decision Date 02/07/1995
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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