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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Condenser, Heat And Moisture (Artificial Nose)
510(k) Number K934441
Device Name KING SYSTEMS HME
Applicant
KING SYSTEMS CORP.
15011 HERRIMAN BLVD.
P.O. BOX 1138
NOBLESVILLE,  IN  46060
Applicant Contact MICHAEL A LEAGRE
Correspondent
KING SYSTEMS CORP.
15011 HERRIMAN BLVD.
P.O. BOX 1138
NOBLESVILLE,  IN  46060
Correspondent Contact MICHAEL A LEAGRE
Regulation Number868.5375
Classification Product Code
BYD  
Date Received09/10/1993
Decision Date 12/02/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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