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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 -6694
Applicant Contact DAN REAGAN
Correspondent
STORZ INSTRUMENT CO.
3365 TREE CT. INDUSTRIAL BLVD.
ST. LOUIS,  MO  63122 -6694
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
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