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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name generator, oxygen, portable
510(k) Number K844328
Device Name OXYGEN CONCENTRATOR
Applicant
HOSPITAK, INC.
1144 ROUTE 109
LINDENHURST,  NY  11757
Applicant Contact WILLIAM J LACEY
Correspondent
HOSPITAK, INC.
1144 ROUTE 109
LINDENHURST,  NY  11757
Correspondent Contact WILLIAM J LACEY
Regulation Number868.5440
Classification Product Code
CAW  
Date Received11/07/1984
Decision Date 12/04/1984
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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