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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, toe, hemi-, phalangeal
510(k) Number K060560
Device Name ASCENSION PYROSPHERE CMC/TMT
Applicant
ASCENSION ORTHOPEDICS, INC.
8700 CAMERON RD., STE. 100
AUSTIN,  TX  78754 -3832
Applicant Contact GLEN NEALLY
Correspondent
ASCENSION ORTHOPEDICS, INC.
8700 CAMERON RD., STE. 100
AUSTIN,  TX  78754 -3832
Correspondent Contact GLEN NEALLY
Regulation Number888.3730
Classification Product Code
KWD  
Date Received03/02/2006
Decision Date 05/05/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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