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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K901237
Device Name GLOVE LEAK DETECTOR
Applicant
Utah Medical Products, Inc.
7043 S. 300 W.
Midvale,  UT  84047
Applicant Contact O GOODMAN
Correspondent
Utah Medical Products, Inc.
7043 S. 300 W.
Midvale,  UT  84047
Correspondent Contact O GOODMAN
Classification Product Code
LDQ
Date Received03/15/1990
Decision Date 08/21/1990
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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