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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, Non-Electric
510(k) Number K973611
Device Name SPECTRASCIENCE REUSABLE BIOPSY FORCEPS
Applicant
Spectrascience, Inc.
3650 Annapolis Lane, Suite 101
Minneapolis,  MN  55447 -5434
Applicant Contact JOHN G YAGER
Correspondent
Spectrascience, Inc.
3650 Annapolis Lane, Suite 101
Minneapolis,  MN  55447 -5434
Correspondent Contact JOHN G YAGER
Regulation Number876.1075
Classification Product Code
FCL  
Subsequent Product Code
GCT  
Date Received09/22/1997
Decision Date 12/02/1997
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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