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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mask, oxygen
510(k) Number K931952
Device Name MEDWAY OXYGEN MASK
Applicant
MEDWAY
2176 HILLSBORO RD.
SUITE 120-362
FRANKLIN,  TN  37064
Applicant Contact JAMES CALLAWAY
Correspondent
MEDWAY
2176 HILLSBORO RD.
SUITE 120-362
FRANKLIN,  TN  37064
Correspondent Contact JAMES CALLAWAY
Regulation Number868.5580
Classification Product Code
BYG  
Date Received04/20/1993
Decision Date 08/20/1993
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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