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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Gauge, Gas Pressure, Cylinder/Pipeline
510(k) Number K942645
Device Name B&F MEDICAL OXYGEN REG MECICAL OXY COMPRESS GAS REG
Applicant
B & F Medical Products, Inc.
Washington Harbour
3000 K St., NW Suite 500
Washington,  DC  20007 -5109
Applicant Contact ILENE KNABLE GOTTS
Correspondent
B & F Medical Products, Inc.
Washington Harbour
3000 K St., NW Suite 500
Washington,  DC  20007 -5109
Correspondent Contact ILENE KNABLE GOTTS
Regulation Number868.2610
Classification Product Code
BXH  
Date Received06/03/1994
Decision Date 07/27/1994
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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