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U.S. Department of Health and Human Services

510(k) Premarket Notification

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510(k) Number K843348
Device Name NISONSON WIRE & DRILL GUIDE SYS
Applicant
Stryker Corp.
420 Alcott St.
Kalamazoo,  MI  49001
Applicant Contact MARY C MASTENBROOK
Correspondent
Stryker Corp.
420 Alcott St.
Kalamazoo,  MI  49001
Correspondent Contact MARY C MASTENBROOK
Date Received08/27/1984
Decision Date 10/31/1984
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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