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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Tubing And Support, Ventilator (W Harness)
510(k) Number K861286
Device Name GAS SAMPLING KIT
Applicant
Respiratory Support Products, Inc.
3183-D Airway Ave.
Costa Mesa,  CA  92626
Applicant Contact ANTHONY V BERAN
Correspondent
Respiratory Support Products, Inc.
3183-D Airway Ave.
Costa Mesa,  CA  92626
Correspondent Contact ANTHONY V BERAN
Regulation Number868.5975
Classification Product Code
BZO  
Date Received04/07/1986
Decision Date 04/11/1986
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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