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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Forceps, Biopsy, Electric, Reprocessed
510(k) Number K050136
Device Name REPROCESSED HOT BIOPSY FORCEPS
Applicant
Sterilmed, Inc.
11400 73rd Ave. N
Maple Grove,  MN  55369
Applicant Contact BRUCE R LESTER
Correspondent
Sterilmed, Inc.
11400 73rd Ave. N
Maple Grove,  MN  55369
Correspondent Contact BRUCE R LESTER
Regulation Number876.4300
Classification Product Code
NLU  
Date Received01/21/2005
Decision Date 07/20/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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