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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Irrigation
510(k) Number K910245
Device Name I/A HANDPIECE WITH REPLACEABLE TIPS
Applicant
Surgical Technologies, Inc.
750 Goddard Ave.
Chesterfield,  MO  63005
Applicant Contact TODD HESSEL
Correspondent
Surgical Technologies, Inc.
750 Goddard Ave.
Chesterfield,  MO  63005
Correspondent Contact TODD HESSEL
Regulation Number878.4200
Classification Product Code
GBX  
Date Received01/22/1991
Decision Date 04/22/1991
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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