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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheters, suction, tracheobronchial
510(k) Number K955831
Device Name ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM
Applicant
SHERWOOD MEDICAL CO.
1915 OLIVE ST.
ST. LOUIS,  MO  63103 -1642
Applicant Contact FRANK FUCILE
Correspondent
SHERWOOD MEDICAL CO.
1915 OLIVE ST.
ST. LOUIS,  MO  63103 -1642
Correspondent Contact FRANK FUCILE
Regulation Number868.6810
Classification Product Code
BSY  
Date Received12/26/1995
Decision Date 03/28/1996
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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