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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Blood Pressure Cuff
510(k) Number K060871
Device Name AS101, BLOOD PRESSURE CUFF
Applicant
Wenzhou Longwan Medical Instrument Company
340 Shady Grove Rd.
Flintville,  TN  37335
Applicant Contact CHARLIE MACK
Correspondent
Wenzhou Longwan Medical Instrument Company
340 Shady Grove Rd.
Flintville,  TN  37335
Correspondent Contact CHARLIE MACK
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received03/30/2006
Decision Date 06/09/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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