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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
Original Applicant
ALLO PRO CORP.
1320 stony brook rd. suite
220
stony brook,  NY  11790
Original Contact larry kluge
Regulation Number888.3330
Classification Product Code
KWA  
Date Received12/07/1988
Decision Date 01/13/1989
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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