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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 K050957
Device Name EUTROCHAR
Applicant
Special Devices, Inc.
12493 Old Rough And Ready Hwy.
Grass Valley,  CA  95945
Applicant Contact JOSEPH J SPRANZA III
Correspondent
Special Devices, Inc.
12493 Old Rough And Ready Hwy.
Grass Valley,  CA  95945
Correspondent Contact JOSEPH J SPRANZA III
Regulation Number878.4800
Classification Product Code
MDM  
Date Received04/15/2005
Decision Date 05/18/2005
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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