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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 K980829
Device Name 3ML STERI-NEB SALINE - 0.9% W/V SODIUM CHLORIDE INHALATION SOLUTION USP
Applicant
Steripak, Ltd.
140 Legrand Ave.
Northvale,  NJ  07647
Applicant Contact JASON A GROSS
Correspondent
Steripak, Ltd.
140 Legrand Ave.
Northvale,  NJ  07647
Correspondent Contact JASON A GROSS
Regulation Number868.5630
Classification Product Code
CAF  
Date Received03/04/1998
Decision Date 06/02/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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