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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Caliper
510(k) Number K921266
Device Name NK MEDICAL MICROMETER, MODEL MC001
Applicant
Nk Biotechnical Engineering Co.
P.O. Box 26335
Minneapolis,  MN  55426
Applicant Contact KAREN GOTGREDSON
Correspondent
Nk Biotechnical Engineering Co.
P.O. Box 26335
Minneapolis,  MN  55426
Correspondent Contact KAREN GOTGREDSON
Regulation Number888.4150
Classification Product Code
KTZ  
Date Received03/16/1992
Decision Date 07/14/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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