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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 K934723
Device Name ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM
Applicant
Sherwood Medical Co.
1915 Olive St.
St. Louis,  MO  63103
Applicant Contact DENNIS POZZO
Correspondent
Sherwood Medical Co.
1915 Olive St.
St. Louis,  MO  63103
Correspondent Contact DENNIS POZZO
Regulation Number868.6810
Classification Product Code
BSY  
Date Received09/30/1993
Decision Date 11/30/1993
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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