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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Sensing, Optical Contour
510(k) Number K844736
Device Name ISIS
Applicant
Oxford Medilog, Inc.
11526 53rd. St. N.
Clearwater,  FL  33520
Applicant Contact JACK M FROST
Correspondent
Oxford Medilog, Inc.
11526 53rd. St. N.
Clearwater,  FL  33520
Correspondent Contact JACK M FROST
Classification Product Code
LDK  
Date Received12/05/1984
Decision Date 03/21/1985
Decision Substantially Equivalent (SESE)
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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