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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter And Tip, Suction
510(k) Number K972372
Device Name GERM TRAPPER SUCTION TUBE HOLDER
Applicant
Rzv Medical Specialties, Inc.
34 Thorncrest Dr.
Pittsburgh,  PA  15235
Applicant Contact LINDA K RUVO
Correspondent
Rzv Medical Specialties, Inc.
34 Thorncrest Dr.
Pittsburgh,  PA  15235
Correspondent Contact LINDA K RUVO
Regulation Number880.6740
Classification Product Code
JOL  
Date Received06/25/1997
Decision Date 12/11/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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