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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clasp, Wire
510(k) Number K881331
Device Name ORTHODONTIC NITINOL SPRINGS
Applicant
Flexmedics
620 Ford Ctr., 420 N. Fifth
St.
Minneapolis,  MN  55401
Applicant Contact SIEVERT, JR.
Correspondent
Flexmedics
620 Ford Ctr., 420 N. Fifth
St.
Minneapolis,  MN  55401
Correspondent Contact SIEVERT, JR.
Regulation Number872.3285
Classification Product Code
EJW  
Date Received03/29/1988
Decision Date 04/21/1988
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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