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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Orthodontic
510(k) Number K934265
Device Name FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIRE
Applicant
Flexmedics
12400 Whitewater Dr., Suite 2040
Minnetonka,  MN  55343
Applicant Contact BRIAN FINANDER
Correspondent
Flexmedics
12400 Whitewater Dr., Suite 2040
Minnetonka,  MN  55343
Correspondent Contact BRIAN FINANDER
Regulation Number872.5410
Classification Product Code
DZC  
Date Received08/31/1993
Decision Date 01/21/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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