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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Condenser, Heat And Moisture (Artificial Nose)
510(k) Number K914336
Device Name BREATHE EASY
Applicant
Vital Signs, Inc.
20 Campus Rd.
Totowa,  NJ  07512
Applicant Contact DENNIS IRLBECK
Correspondent
Vital Signs, Inc.
20 Campus Rd.
Totowa,  NJ  07512
Correspondent Contact DENNIS IRLBECK
Regulation Number868.5375
Classification Product Code
BYD  
Date Received09/27/1991
Decision Date 03/25/1992
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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