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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 K933151
Device Name CONVENIENCE CONTOUR KITS REDI NURSE SYSTEM
Applicant
Contour Fabricators of Florida, Inc.
3340 Scherer Dr.
St. Petersburg,  FL  33716
Applicant Contact SCOTT WILLIAMS
Correspondent
Contour Fabricators of Florida, Inc.
3340 Scherer Dr.
St. Petersburg,  FL  33716
Correspondent Contact SCOTT WILLIAMS
Regulation Number880.6850
Classification Product Code
FRG  
Date Received06/29/1993
Decision Date 12/13/1993
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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