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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
Predetermined Change
Control Plan Authorized		 No
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