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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sound, Metal, Interconnected
510(k) Number K954972
Device Name LYELL SOUND
Applicant
Venture Management Corp.
2323 Curlew Rd.
Suite 2-E
Palm Harbor,  FL  34683
Applicant Contact GENE ZAMBA
Correspondent
Venture Management Corp.
2323 Curlew Rd.
Suite 2-E
Palm Harbor,  FL  34683
Correspondent Contact GENE ZAMBA
Regulation Number876.4590
Classification Product Code
FBS  
Date Received10/27/1995
Decision Date 01/24/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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