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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 K953466
Device Name GENERICUFF
Applicant
Generic Medical, Inc.
2880 Holcomb Bridge Rd.
# B-9 1124
Alpharetta,  GA  30004
Applicant Contact DAVID L WALSH
Correspondent
Generic Medical, Inc.
2880 Holcomb Bridge Rd.
# B-9 1124
Alpharetta,  GA  30004
Correspondent Contact DAVID L WALSH
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received07/24/1995
Decision Date 09/15/1995
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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