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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name General Surgery Tray
510(k) Number K932217
Device Name MAJOR, MINOR, BASIN TRAYS (PACKS)
Applicant
Associated Medical Products Co.
3250 Gorham Ave.
St. Louis Park,  MN  55426
Applicant Contact SCOTT WEISS
Correspondent
Associated Medical Products Co.
3250 Gorham Ave.
St. Louis Park,  MN  55426
Correspondent Contact SCOTT WEISS
Regulation Number878.4370
Classification Product Code
LRO  
Date Received05/07/1993
Decision Date 11/15/1993
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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