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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Brace, Drill
510(k) Number K880381
Device Name TELOS DISTAL TARGETING DEVICE
Applicant
Austin Assoc.
1109 Sturbridge Rd.
Fallston,,  MD  21047
Applicant Contact ALBERT G AUSTIN
Correspondent
Austin Assoc.
1109 Sturbridge Rd.
Fallston,,  MD  21047
Correspondent Contact ALBERT G AUSTIN
Regulation Number888.4540
Classification Product Code
HXY  
Date Received01/27/1988
Decision Date 03/15/1988
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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