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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
510(k) Number K861264
Device Name JOINT MEASUREMENT INDICATOR
Applicant
Devcom, Inc.
1010 Valley Forge Plz.
King Of Prussia,  PA  19406
Applicant Contact STEVEN GROSS
Correspondent
Devcom, Inc.
1010 Valley Forge Plz.
King Of Prussia,  PA  19406
Correspondent Contact STEVEN GROSS
Regulation Number888.3320
Classification Product Code
JDL  
Date Received04/04/1986
Decision Date 04/15/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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