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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K072394
Device Name PORTRAIT STAND-OFF
Applicant
Rhytec Incorporated
130 Turner St.
Bldg. 2
Waltham,  MA  02453
Applicant Contact Robert Zoletti
Correspondent
Rhytec Incorporated
130 Turner St.
Bldg. 2
Waltham,  MA  02453
Correspondent Contact Robert Zoletti
Regulation Number878.4400
Classification Product Code
GEI  
Date Received08/27/2007
Decision Date 09/12/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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