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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filler, Bone Void, Calcium Compound
510(k) Number K071428
Device Name INQU
Applicant
Isto Technologies, Inc.
5600 Wisconsin Ave., # 509
Chevy Chase,  MD  20815
Applicant Contact PATSY J TRISLER
Correspondent
Isto Technologies, Inc.
5600 Wisconsin Ave., # 509
Chevy Chase,  MD  20815
Correspondent Contact PATSY J TRISLER
Regulation Number888.3045
Classification Product Code
MQV  
Date Received05/23/2007
Decision Date 09/17/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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