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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy
510(k) Number K142791
Device Name Spectra Soft Tissue Biopsy Needles
Applicant
Spectra Medical Devices
260-F & H Fordham Rd.
Wilmington,  MA  01887
Applicant Contact Agustin Turriza
Correspondent
Spectra Medical Devices, Inc.
299 Ballardvale St., Suite I,
Wilmington,  MA  01887
Correspondent Contact Kathy Dassler
Regulation Number876.1075
Classification Product Code
KNW  
Date Received09/26/2014
Decision Date 01/21/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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