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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K827708
Device Name ULTRASONIC MEDICAL DEVICE MODEL 3 LO 4
Applicant
Sterisson
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Sterisson
803 N. Front St. Suite 3
Mchenry,  IL  60050
Date Received07/12/1982
Decision Date 04/12/1983
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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