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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 Uncemented Acetabular Component)
510(k) Number K885049
Device Name RS-CUP ACETABULAR PROSTHESIS
Applicant
Allo Pro Corp.
1320 Stony Brook Rd. Suite
220
Stony Brook,  NY  11790
Applicant Contact LARRY KLUGE
Correspondent
Allo Pro Corp.
1320 Stony Brook Rd. Suite
220
Stony Brook,  NY  11790
Correspondent Contact LARRY KLUGE
Regulation Number888.3330
Classification Product Code
KWA  
Date Received12/07/1988
Decision Date 01/13/1989
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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