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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mixer, Breathing Gases, Anesthesia Inhalation
510(k) Number K811393
Device Name DOWNS CAP FLOW GENERATOR
Applicant
Vital Signs, Inc.
1 Madison St.
East Rutherford,  NJ  07073
Applicant Contact Terence D Wall
Correspondent
Vital Signs, Inc.
1 Madison St.
East Rutherford,  NJ  07073
Correspondent Contact Terence D Wall
Regulation Number868.5330
Classification Product Code
BZR  
Date Received05/18/1981
Decision Date 06/09/1981
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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