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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Osteotome, Manual
510(k) Number K852541
Device Name STORZ ION BOND OSTEOTOMES & RASPS, FAST CU BURS
Applicant
Storz Instrument Co.
3365 Tree Ct. Industrial Blvd.
St. Louis,  MO  63122
Applicant Contact DAN REAGAN
Correspondent
Storz Instrument Co.
3365 Tree Ct. Industrial Blvd.
St. Louis,  MO  63122
Correspondent Contact DAN REAGAN
Regulation Number878.4800
Classification Product Code
GFI  
Date Received06/14/1985
Decision Date 07/11/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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