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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K844788
Device Name SOLEO SUNBED
Applicant
Hapro International B.V.
5475 Crestview Dr.
Memphis,  TN  38134
Applicant Contact FAYE R LONGO
Correspondent
Hapro International B.V.
5475 Crestview Dr.
Memphis,  TN  38134
Correspondent Contact FAYE R LONGO
Date Received12/10/1984
Decision Date 02/07/1985
Decision Substantially Equivalent (SESE)
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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