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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name nebulizer (direct patient interface)
510(k) Number K911807
Device Name METERED DOSE INHALER (MDI) SPACER
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 Number868.5630
Classification Product Code
CAF  
Date Received04/23/1991
Decision Date 10/23/1991
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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