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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 K831479
Device Name METAL-BACKED ACETABULAR CUP
Applicant
Dow Corning Corp. Healthcare Industries Materials
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Dow Corning Corp. Healthcare Industries Materials
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received05/09/1983
Decision Date 06/15/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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