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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 K942101
Device Name 4-LEAD IRRIGATION SET
Applicant
Douglas Medical Products Corp.
345 Dunbar Rd.
Mundelein,  IL  60060
Applicant Contact DOUGLAS JOHNSON
Correspondent
Douglas Medical Products Corp.
345 Dunbar Rd.
Mundelein,  IL  60060
Correspondent Contact DOUGLAS JOHNSON
Regulation Number888.1100
Classification Product Code
HRX  
Date Received05/02/1994
Decision Date 09/30/1994
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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