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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K935092
Device Name CONVENIENCE CONTOUR KITS REDI NURSE SYSTEM
Applicant
Contour Fabricators of Florida, Inc.
3340-D Scherer Dr.
St. Petersburg,  FL  33716
Applicant Contact SCOTT WILLIAMS
Correspondent
Contour Fabricators of Florida, Inc.
3340-D Scherer Dr.
St. Petersburg,  FL  33716
Correspondent Contact SCOTT WILLIAMS
Regulation Number880.5860
Classification Product Code
FMF  
Date Received10/25/1993
Decision Date 06/10/1994
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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