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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
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