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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Therapeutic, Electric
510(k) Number K990445
Device Name LPG THERAPEUTIC MASSAGER, MODELS -ESI, THERAPEUTIC MASSAGER/VIBRATOR
Applicant
Lpg USA, Inc.
3101 N. Federal Hwy. #300
Fort Lauderdale,  FL  33306
Applicant Contact JOCELYNE ROLLAND
Correspondent
Lpg USA, Inc.
3101 N. Federal Hwy. #300
Fort Lauderdale,  FL  33306
Correspondent Contact JOCELYNE ROLLAND
Regulation Number890.5660
Classification Product Code
ISA  
Date Received02/10/1999
Decision Date 01/18/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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