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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handle, Scalpel
510(k) Number K091462
Device Name SPECTRA MEDICAL SAFETY SCAPEL
Applicant
SPECTRA, INC.
260 F&H FORDHAM ROAD
WILMINGTON,  MA  01887
Applicant Contact AGUSTIN TURRIZA
Correspondent
SPECTRA, INC.
260 F&H FORDHAM ROAD
WILMINGTON,  MA  01887
Correspondent Contact AGUSTIN TURRIZA
Regulation Number878.4800
Classification Product Code
GDZ  
Subsequent Product Code
GES  
Date Received05/18/2009
Decision Date 12/15/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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