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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K960771
Device Name SLAV AND SLAV-ONE INJECTION PORT CONNECTOR SYSTEM
Applicant
Rymed Technologies, Inc.
3110 Blue Sage Dr.
Woodward,  OK  73801
Applicant Contact DANA W RYAN
Correspondent
Rymed Technologies, Inc.
3110 Blue Sage Dr.
Woodward,  OK  73801
Correspondent Contact DANA W RYAN
Regulation Number880.5440
Classification Product Code
FPA  
Date Received02/26/1996
Decision Date 12/10/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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