PROTECT DROPS/SAME AS K874070

Liner, Cavity, Calcium Hydroxide

JOHN O. BUTLER

The following data is part of a premarket notification filed by John O. Butler with the FDA for Protect Drops/same As K874070.

Pre-market Notification Details

Device IDK874194
510k NumberK874194
Device Name:PROTECT DROPS/SAME AS K874070
ClassificationLiner, Cavity, Calcium Hydroxide
Applicant JOHN O. BUTLER 333 WEST WACKER DR. SUITE 1900 Chicago,  IL  60606
ContactA Marcouiller
CorrespondentA Marcouiller
JOHN O. BUTLER 333 WEST WACKER DR. SUITE 1900 Chicago,  IL  60606
Product CodeEJK  
CFR Regulation Number872.3250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-10-14
Decision Date1987-12-16

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