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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chamber, Oxygen, Topical, Extremity
510(k) Number K882461
Device Name O2 CARE
Applicant
Ballard Medical Products
6864 S. 300 W.
Midvale,  UT  84047
Applicant Contact ERNEST CHAMBERLAIN
Correspondent
Ballard Medical Products
6864 S. 300 W.
Midvale,  UT  84047
Correspondent Contact ERNEST CHAMBERLAIN
Regulation Number878.5650
Classification Product Code
KPJ  
Date Received06/15/1988
Decision Date 11/28/1988
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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