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U.S. Department of Health and Human Services

510(k) Premarket Notification

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510(k) Number K861161
Device Name SURGI-TIE LOOPS
Applicant
Healthmed Corp.
2815 Baird Rd.
Fairport,  NY  14450
Applicant Contact D. L FAGAN
Correspondent
Healthmed Corp.
2815 Baird Rd.
Fairport,  NY  14450
Correspondent Contact D. L FAGAN
Date Received03/28/1986
Decision Date 06/10/1986
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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