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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 K820777
Device Name MINI-MICRO ARTHROSCOPIC SCAPEL
Applicant
THE ANSPACH EFFORT, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
THE ANSPACH EFFORT, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number888.1100
Classification Product Code
HRX  
Date Received03/23/1982
Decision Date 05/12/1982
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
Recalls CDRH Recalls
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