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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clip, Implantable
510(k) Number K072525
Device Name ZIPKNOT, MODEL 1017-3000
Applicant
MEDICINELODGE, INC.
180 SOUTH 600 WEST
LOGAN,  UT  84321
Applicant Contact MARY SINNOTT
Correspondent
MEDICINELODGE, INC.
180 SOUTH 600 WEST
LOGAN,  UT  84321
Correspondent Contact MARY SINNOTT
Regulation Number878.4300
Classification Product Code
FZP  
Date Received09/07/2007
Decision Date 10/05/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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