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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, Hemi-, Femoral, Metal
510(k) Number K842465
Device Name UNILOC
Applicant
American Ortomed Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Applicant Contact MICHAEL M STEK
Correspondent
American Ortomed Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent Contact MICHAEL M STEK
Regulation Number888.3360
Classification Product Code
KWL  
Date Received06/25/1984
Decision Date 11/19/1984
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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