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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Column Chromatography & Color Development, Hydroxyproline
510(k) Number K945946
Device Name OSTEOMARK(R)
Applicant
Ostex Intl., Inc.
2203 Airport Way S.
Suite 400
Seattle,  WA  98134
Applicant Contact NANCY J S. MALLINAK
Correspondent
Ostex Intl., Inc.
2203 Airport Way S.
Suite 400
Seattle,  WA  98134
Correspondent Contact NANCY J S. MALLINAK
Regulation Number862.1400
Classification Product Code
JMM  
Date Received12/05/1994
Decision Date 05/08/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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