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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Emergency, Powered (Resuscitator)
510(k) Number K853971
Device Name REGULATOR-INHALATOR SYSTEM
Applicant
STEPHENSON INDUSTRIES, INC.
P. O. BOX 1000
FARMINGDALE,  NJ  07727
Applicant Contact LASLEY
Correspondent
STEPHENSON INDUSTRIES, INC.
P. O. BOX 1000
FARMINGDALE,  NJ  07727
Correspondent Contact LASLEY
Regulation Number868.5925
Classification Product Code
BTL  
Date Received09/26/1985
Decision Date 12/09/1985
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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