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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wrap, Sterilization
510(k) Number K935238
Device Name ARGYLE TURKEL SAFETY PARACENTESIS PROCEDURE TRAY
Applicant
Sherwood Medical Co.
1915 Olive St.
St. Louis,  MO  63103
Applicant Contact FRANK J FUCILE
Correspondent
Sherwood Medical Co.
1915 Olive St.
St. Louis,  MO  63103
Correspondent Contact FRANK J FUCILE
Regulation Number880.6850
Classification Product Code
FRG  
Subsequent Product Code
LRO  
Date Received11/01/1993
Decision Date 02/17/1994
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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