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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 K852592
Device Name CO2 FOR ARTHROSCOPY
Applicant
THE ANSPACH EFFORT, INC.
1349 S. KILLIAN DR.
LAKE PARK,  FL  33403
Applicant Contact W. E ANSPACH
Correspondent
THE ANSPACH EFFORT, INC.
1349 S. KILLIAN DR.
LAKE PARK,  FL  33403
Correspondent Contact W. E ANSPACH
Regulation Number888.1100
Classification Product Code
HRX  
Date Received06/19/1985
Decision Date 08/09/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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