PEDIA PALS, INCORPORATED

Speculum, Ent

PEDIA PALS, INC.

The following data is part of a premarket notification filed by Pedia Pals, Inc. with the FDA for Pedia Pals, Incorporated.

Pre-market Notification Details

Device IDK950086
510k NumberK950086
Device Name:PEDIA PALS, INCORPORATED
ClassificationSpeculum, Ent
Applicant PEDIA PALS, INC. 3939 INTERNATIONAL GATEWAY Columbus,  OH  43219
ContactDavid L Barnes
CorrespondentDavid L Barnes
PEDIA PALS, INC. 3939 INTERNATIONAL GATEWAY Columbus,  OH  43219
Product CodeEPY  
CFR Regulation Number878.1800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-01-10
Decision Date1995-02-07

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