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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mask, oxygen, low concentration, venturi
510(k) Number K955483
Device Name TRACH MASK MODEL (245, 246)
Applicant
HOSPITAK, INC.
10 DANIEL ST.
FARMINGDALE,  NY  11735
Applicant Contact WILLIAM LACEY
Correspondent
HOSPITAK, INC.
10 DANIEL ST.
FARMINGDALE,  NY  11735
Correspondent Contact WILLIAM LACEY
Regulation Number868.5600
Classification Product Code
BYF  
Date Received12/01/1995
Decision Date 02/28/1996
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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