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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K837178
Device Name STANDEX SYSTEM
Applicant
Elscint, Inc.
505 Main St.
Suite 300
Hackensack,  NJ  07601
Correspondent
Elscint, Inc.
505 Main St.
Suite 300
Hackensack,  NJ  07601
Date Received02/16/1983
Decision Date 03/22/1983
Decision Substantially Equivalent (SESE)
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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