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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
510(k) Number K022751
Device Name REPROCESSED USED DISPOSABLE HOT AND COLD BIOPSY FORCEPS
Applicant
MEDICAL DEVICE SERVICES
144 WEST BRIGHAM RD.
BLDG E
ST. GEORGE,  UT  84790
Applicant Contact MARK ALDANA
Correspondent
MEDICAL DEVICE SERVICES
144 WEST BRIGHAM RD.
BLDG E
ST. GEORGE,  UT  84790
Correspondent Contact MARK ALDANA
Regulation Number876.4300
Classification Product Code
KGE  
Subsequent Product Code
FCL  
Date Received08/19/2002
Decision Date 11/04/2002
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
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