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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 K991653
Device Name INVISION-PLUS INJECTION PORT CONNECTOR SYSTEM
Applicant
RYMED TECHNOLOGIES, INC.
19526 EAST LAKE DR.
MIAMI,  FL  33015
Applicant Contact AL WEISENBORN
Correspondent
RYMED TECHNOLOGIES, INC.
19526 EAST LAKE DR.
MIAMI,  FL  33015
Correspondent Contact AL WEISENBORN
Regulation Number880.5440
Classification Product Code
FPA  
Date Received05/13/1999
Decision Date 06/24/1999
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
Recalls CDRH Recalls
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