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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K854621
Device Name ISOSTATION KNEE MACHINE (K-100)
Applicant
Isotechnologies, Inc.
P.O. Box 1239
Hillsborough,  NC  27278
Applicant Contact MARTIN
Correspondent
Isotechnologies, Inc.
P.O. Box 1239
Hillsborough,  NC  27278
Correspondent Contact MARTIN
Date Received11/18/1985
Decision Date 03/07/1986
Decision Substantially Equivalent (SESE)
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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