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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Cartridge
510(k) Number K023722
Device Name SAFETYWAND DISPOSABLE HANDPIECE
Applicant
Spintech, Inc.
2000 M St. NW Suite 700
Washington,  DC  20036
Applicant Contact DANIEL J MANELLI
Correspondent
Spintech, Inc.
2000 M St. NW Suite 700
Washington,  DC  20036
Correspondent Contact DANIEL J MANELLI
Regulation Number872.6770
Classification Product Code
EJI  
Date Received11/05/2002
Decision Date 09/02/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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