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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 K963793
Device Name OPTIVENT
Applicant
Health Care Products, Inc.
908 Pompton Ave.
Unit B2
Cedar Grove,  NJ  07009 -1292
Applicant Contact LAUREN R ZIEGLER
Correspondent
Health Care Products, Inc.
908 Pompton Ave.
Unit B2
Cedar Grove,  NJ  07009 -1292
Correspondent Contact LAUREN R ZIEGLER
Regulation Number868.5630
Classification Product Code
CAF  
Date Received09/23/1996
Decision Date 04/16/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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