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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Urological
510(k) Number K873448
Device Name FOLEY CATHETER TEMPERATURE SENSOR
Applicant
RESPIRATORY SUPPORT PRODUCTS, INC.
3118 ALPINE
SANTA ANA,  CA  92704
Applicant Contact ANTHONY V BERAN
Correspondent
RESPIRATORY SUPPORT PRODUCTS, INC.
3118 ALPINE
SANTA ANA,  CA  92704
Correspondent Contact ANTHONY V BERAN
Regulation Number876.5130
Classification Product Code
KOD  
Date Received08/26/1987
Decision Date 12/07/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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