FDA.report

510(k) K920988

Device
ATMOS MIRROR WARMER
Applicant
JEDMED INSTRUMENT CO.
510(k) number
K920988
Product code
LRC  
Decision
Substantially Equivalent (SESE)
Decision date
1992-05-15
Date received
1992-03-02
Regulation
874.4420
Classification name
Instrument, Ent Manual Surgical
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
CRAIG RAPP
Address
6096 Lemay Ferry Rd. St.Louis MO US 63129 63129

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Legacy Summary

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FDA Review

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