EAR SPECULI

Speculum, Ent

KELLEHER CORP.

The following data is part of a premarket notification filed by Kelleher Corp. with the FDA for Ear Speculi.

Pre-market Notification Details

Device IDK822164
510k NumberK822164
Device Name:EAR SPECULI
ClassificationSpeculum, Ent
Applicant KELLEHER CORP. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeEPY  
CFR Regulation Number878.1800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-07-23
Decision Date1982-08-11

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