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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name spirometer, therapeutic (incentive)
510(k) Number K992256
Device Name FROLOV'S RESPIRATION TRAINING DEVICE, FRTD-01
Applicant
INTERCONTINENTAL NEW TECHNOLOGIES, INC.
PO BOX 7007
DEERFIELD,  IL  60015
Applicant Contact DANIEL KAMM
Correspondent
INTERCONTINENTAL NEW TECHNOLOGIES, INC.
PO BOX 7007
DEERFIELD,  IL  60015
Correspondent Contact DANIEL KAMM
Regulation Number868.5690
Classification Product Code
BWF  
Date Received07/06/1999
Decision Date 01/11/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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