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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 K921499
Device Name SEAL RING FOR NASAL CPAP
Applicant
Devilbiss Health Care, Inc.
1200 E. Main St.
P.O.Box 635
Somerset,  PA  15501
Applicant Contact DAVID L GAST
Correspondent
Devilbiss Health Care, Inc.
1200 E. Main St.
P.O.Box 635
Somerset,  PA  15501
Correspondent Contact DAVID L GAST
Regulation Number868.5580
Classification Product Code
BYG  
Date Received03/31/1992
Decision Date 09/17/1992
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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