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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 K853039
Device Name PRESSURE REGULATOR
Applicant
ERIE MEDICAL
4000 SOUTH 13TH ST.
MILWAUKEE,  WI  53221
Applicant Contact STEVEN A CASE
Correspondent
ERIE MEDICAL
4000 SOUTH 13TH ST.
MILWAUKEE,  WI  53221
Correspondent Contact STEVEN A CASE
Regulation Number868.2700
Classification Product Code
CAN  
Date Received07/19/1985
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
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