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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bath, Hydro-Massage
510(k) Number K910607
Device Name PACIFIC MARQUIS SPA
Applicant
Marquis International , Ltd.
32 N. Duke St.
P.O. Box 544
York,  PA  17405
Applicant Contact MICHAEL J KROUT
Correspondent
Marquis International , Ltd.
32 N. Duke St.
P.O. Box 544
York,  PA  17405
Correspondent Contact MICHAEL J KROUT
Regulation Number890.5100
Classification Product Code
ILJ  
Date Received02/12/1991
Decision Date 02/21/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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