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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 K935553
Device Name MULLY SUCTION STRAIGHT WITH FINGERTIP/WITH FUNNEL/WITH VACUTIP
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 Received11/17/1993
Decision Date 01/14/1994
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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