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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 K912943
Device Name THRESHOLD 2X INSPIRATORY MUSCLE TRAINER
Applicant
HEALTH PRODUCTS, INC.
908 POMPTON AVE.
UNIT B2
CEDAR GROVE,  NJ  07009
Applicant Contact LAUREN R ZIEGLER
Correspondent
HEALTH PRODUCTS, INC.
908 POMPTON AVE.
UNIT B2
CEDAR GROVE,  NJ  07009
Correspondent Contact LAUREN R ZIEGLER
Regulation Number868.5690
Classification Product Code
BWF  
Date Received07/05/1991
Decision Date 01/30/1992
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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