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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name instrument, ent manual surgical
510(k) Number K920988
Device Name ATMOS MIRROR WARMER
Applicant
JEDMED INSTRUMENT CO.
6096 LEMAY FERRY RD.
ST.LOUIS,  MO  63129 -2217
Applicant Contact CRAIG RAPP
Correspondent
JEDMED INSTRUMENT CO.
6096 LEMAY FERRY RD.
ST.LOUIS,  MO  63129 -2217
Correspondent Contact CRAIG RAPP
Regulation Number874.4420
Classification Product Code
LRC  
Date Received03/02/1992
Decision Date 05/15/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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