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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Percussor, Powered-Electric
510(k) Number K892862
Device Name FLEX-CUP PERCUSSOR
Applicant
Life Design Systems, Inc.
2735 E. Beltline Rd.
Carrollton,  TX  75006
Applicant Contact JUDY UDVARE
Correspondent
Life Design Systems, Inc.
2735 E. Beltline Rd.
Carrollton,  TX  75006
Correspondent Contact JUDY UDVARE
Regulation Number868.5665
Classification Product Code
BYI  
Date Received04/18/1989
Decision Date 05/25/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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