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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Arthroscope
510(k) Number K904479
Device Name SURGICAL INST.:1030,1010,1011,1012,1013,1014,1015
Applicant
Percutaneous Technologies
773 Trotter Ct.
Walnut,  CA  91789
Applicant Contact WILLIAM MEYER
Correspondent
Percutaneous Technologies
773 Trotter Ct.
Walnut,  CA  91789
Correspondent Contact WILLIAM MEYER
Regulation Number888.1100
Classification Product Code
HRX  
Date Received10/02/1990
Decision Date 11/02/1990
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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