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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Manual, Surgical, General Use
510(k) Number K013040
Device Name LIGHT SABER INTRODUCER NEEDLE
Applicant
Minrad, Inc.
555 Thirdteenth St., NW
Washington,  DC  20004
Applicant Contact HOWARD M HOLSTEIN
Correspondent
Minrad, Inc.
555 Thirdteenth St., NW
Washington,  DC  20004
Correspondent Contact HOWARD M HOLSTEIN
Regulation Number878.4800
Classification Product Code
MDM  
Date Received09/10/2001
Decision Date 12/07/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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