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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 K945482
Device Name DISPOSABLE, CPAP OXYGEN MASK
Applicant
Fvtnks
67920 Klinger Lake Rd.
Sturgis,  MI  49091
Applicant Contact PAUL E DRYDEN
Correspondent
Fvtnks
67920 Klinger Lake Rd.
Sturgis,  MI  49091
Correspondent Contact PAUL E DRYDEN
Regulation Number868.5580
Classification Product Code
BYG  
Date Received11/08/1994
Decision Date 09/19/1995
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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