JMS HALO APPLICATION TRAY

Kit, Surgical Instrument, Disposable

JEROME MEDICAL

The following data is part of a premarket notification filed by Jerome Medical with the FDA for Jms Halo Application Tray.

Pre-market Notification Details

Device IDK864969
510k NumberK864969
Device Name:JMS HALO APPLICATION TRAY
ClassificationKit, Surgical Instrument, Disposable
Applicant JEROME MEDICAL 102 GAITHER DR. Mt Laurel,  NJ  08054
ContactSuzanne B Beacher
CorrespondentSuzanne B Beacher
JEROME MEDICAL 102 GAITHER DR. Mt Laurel,  NJ  08054
Product CodeKDD  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent - With Drug (SESD)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-12-22
Decision Date1987-02-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05690977196636 K864969 000

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