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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 K863742
Device Name FLEXMEDICS NITINOL ARCH WIRE
Applicant
Flexmedics
Section 12
1313 Fifth St., SE
Minneapolis,  MN  55414
Applicant Contact SIEVERT, JR.
Correspondent
Flexmedics
Section 12
1313 Fifth St., SE
Minneapolis,  MN  55414
Correspondent Contact SIEVERT, JR.
Regulation Number872.5410
Classification Product Code
DZC  
Date Received09/23/1986
Decision Date 11/24/1986
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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