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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 K935583
Device Name SUCTION SET, TRACHAEL
Applicant
PURITAS HEALTH CARE, INC.
219 KENT RD.
SUITE 20
NEW MILFORD,  CT  06776
Applicant Contact THOMAS P DIMAIO
Correspondent
PURITAS HEALTH CARE, INC.
219 KENT RD.
SUITE 20
NEW MILFORD,  CT  06776
Correspondent Contact THOMAS P DIMAIO
Regulation Number868.6810
Classification Product Code
BSY  
Date Received11/18/1993
Decision Date 04/11/1994
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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