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U.S. Department of Health and Human Services

510(k) Premarket Notification

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510(k) Number K863854
Device Name P.M.D. INTRAMEDULLARY CEMENT RESTRICTOR PLUG
Applicant
Precision Medical Devices, Inc.
1400 Mrket St. Suite 101
Camp Hill,  PA  17011
Applicant Contact EVERHART, JR.
Correspondent
Precision Medical Devices, Inc.
1400 Mrket St. Suite 101
Camp Hill,  PA  17011
Correspondent Contact EVERHART, JR.
Date Received10/02/1986
Decision Date 11/19/1986
Decision Substantially Equivalent (SESE)
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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