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U.S. Department of Health and Human Services

510(k) Premarket Notification

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510(k) Number K863563
Device Name URESIL RADIOPAQUE SILICONE BANDS
Applicant
Uresil Corp.
5418 W. Touhy Ave.
Skokie,  IL  60077
Applicant Contact MICHAEL JARON
Correspondent
Uresil Corp.
5418 W. Touhy Ave.
Skokie,  IL  60077
Correspondent Contact MICHAEL JARON
Date Received09/12/1986
Decision Date 10/02/1986
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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