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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 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 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
Predetermined Change
Control Plan Authorized		 No
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