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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 K063359
Device Name INQU
Applicant
Isto Technologies, Inc.
1155 Olivette Exec. Pkwy.
Suite 200
St. Louis,  MO  63132
Applicant Contact GARY GAGE
Correspondent
Isto Technologies, Inc.
1155 Olivette Exec. Pkwy.
Suite 200
St. Louis,  MO  63132
Correspondent Contact GARY GAGE
Regulation Number888.3045
Classification Product Code
MQV  
Date Received11/07/2006
Decision Date 04/16/2007
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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