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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K870156
Device Name FLEXMEDICS NITINOL MAMMORY 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.
Date Received01/13/1987
Decision Date 02/24/1987
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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