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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Irrigating (Non Dental)
510(k) Number K952406
Device Name REDI NURSE SYSTEM (RNS) PRE-FILLED 60CC IRRIGATION SYRINGE W/STERILE SODIUM CHLORIDE SOLUTION
Applicant
Contour Fabricators of Florida, Inc.
3340-D Scherer Dr.
St. Petersburg,  FL  33716
Applicant Contact SCOTT WIL;LIAMS
Correspondent
Contour Fabricators of Florida, Inc.
3340-D Scherer Dr.
St. Petersburg,  FL  33716
Correspondent Contact SCOTT WIL;LIAMS
Regulation Number880.6960
Classification Product Code
KYZ  
Date Received05/22/1995
Decision Date 08/07/1995
Decision Substantially Equivalent (SESE)
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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