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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K010692
Device Name THE WAND PLUS COMPUTER CONTROLLED ANESTHETIC DELIVERY SYSTEM
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 Number880.5860
Classification Product Code
FMF  
Subsequent Product Code
EJI  
Date Received03/08/2001
Decision Date 06/29/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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