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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, peritoneal
510(k) Number K933510
Device Name ARGYLE TURKEL SAFETY TROCAR THORACIC CATHETER
Applicant
SHERWOOD MEDICAL CO.
1915 OLIVE ST.
ST. LOUIS,  MO  63103 -1625
Applicant Contact K. MICHAEL KROEHNKE
Correspondent
SHERWOOD MEDICAL CO.
1915 OLIVE ST.
ST. LOUIS,  MO  63103 -1625
Correspondent Contact K. MICHAEL KROEHNKE
Regulation Number878.4200
Classification Product Code
GBW  
Subsequent Product Code
GCJ  
Date Received07/20/1993
Decision Date 02/24/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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