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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheters, suction, tracheobronchial
510(k) Number K945994
Device Name DUAL PURPOSE CATHETER
Applicant
UNIVERSAL MEDICAL PRODUCTS, INC.
10 SCOTT ST.
NEW BRUNSWICK,  NJ  08901
Applicant Contact WALTER JINOTTI
Correspondent
UNIVERSAL MEDICAL PRODUCTS, INC.
10 SCOTT ST.
NEW BRUNSWICK,  NJ  08901
Correspondent Contact WALTER JINOTTI
Regulation Number868.6810
Classification Product Code
BSY  
Date Received11/22/1994
Decision Date 06/21/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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