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U.S. Department of Health and Human Services

510(k) Premarket Notification

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510(k) Number K930884
Device Name MEDICAL PROCEDURE TRAY, MODIFICATION
Applicant
Enpak Medical Corp.
2440 S. Progress Dr.
Salt Lake City,  UT  84119
Applicant Contact SCOTT CRAWFORD
Correspondent
Enpak Medical Corp.
2440 S. Progress Dr.
Salt Lake City,  UT  84119
Correspondent Contact SCOTT CRAWFORD
Classification Product Code
LDQ
Date Received02/17/1993
Decision Date 03/21/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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