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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Angioscope
510(k) Number K913763
Device Name INTERPRET(TM) CATHETER LINEAR TRANSLATOR
Applicant
Intertherapy, Inc.
1936 E. Deere Ave., Suite 120
Santa Ana,  CA  92705
Applicant Contact THOMAS P SCHROEDER
Correspondent
Intertherapy, Inc.
1936 E. Deere Ave., Suite 120
Santa Ana,  CA  92705
Correspondent Contact THOMAS P SCHROEDER
Regulation Number876.1500
Classification Product Code
LYK  
Date Received08/22/1991
Decision Date 11/20/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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