RULE, PUPILLARY

Distometer

ALLEGHENY PLASTICS, INC.

The following data is part of a premarket notification filed by Allegheny Plastics, Inc. with the FDA for Rule, Pupillary.

Pre-market Notification Details

Device IDK873440
510k NumberK873440
Device Name:RULE, PUPILLARY
ClassificationDistometer
Applicant ALLEGHENY PLASTICS, INC. THORN RUN RD. & RT 51 Coraopolis,  PA  15108
ContactDouglas F Turner
CorrespondentDouglas F Turner
ALLEGHENY PLASTICS, INC. THORN RUN RD. & RT 51 Coraopolis,  PA  15108
Product CodeHMM  
CFR Regulation Number886.1190 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-08-27
Decision Date1987-09-21

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