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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Knife, Orthopedic
510(k) Number K930507
Device Name CUSTOM ORTHOPAEDIC TRAYS (PACKS)
Applicant
Associated Medical Products Co.
3250 Gorham Ave.
St. Louis Park,  MN  55426
Applicant Contact SCOTT WIEST
Correspondent
Associated Medical Products Co.
3250 Gorham Ave.
St. Louis Park,  MN  55426
Correspondent Contact SCOTT WIEST
Regulation Number888.4540
Classification Product Code
HTS  
Date Received02/01/1993
Decision Date 02/22/1994
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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