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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 K974056
Device Name 0.9.% SODIUM CHLORIDE INHALATION SOLUTION, USP
Applicant
HOLOPACK INTERNATIONAL, LP
1 TECHNOLOGY CIRCLE
COLUMBIA,,  SC  29203
Applicant Contact JOHN J BARTHE
Correspondent
HOLOPACK INTERNATIONAL, LP
1 TECHNOLOGY CIRCLE
COLUMBIA,,  SC  29203
Correspondent Contact JOHN J BARTHE
Regulation Number868.5630
Classification Product Code
CAF  
Date Received10/27/1997
Decision Date 01/21/1998
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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