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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name regulator, pressure, gas cylinder
510(k) Number K901831
Device Name PRECISION MEDICAL OXYGEN REGULATOR
Applicant
PRECISION MEDICAL, INC.
300 HELD DR.
NORTHAMPTON,  PA  18067
Applicant Contact JOHN R SELADY
Correspondent
PRECISION MEDICAL, INC.
300 HELD DR.
NORTHAMPTON,  PA  18067
Correspondent Contact JOHN R SELADY
Regulation Number868.2700
Classification Product Code
CAN  
Date Received04/24/1990
Decision Date 08/14/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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