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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Roller
510(k) Number K852506
Device Name BIOGLAS MICROCARRIER BEAD
Applicant
Solohill Engineering, Inc.
323 E. William, Suite 44
Ann Arbor,  MI  48104
Applicant Contact WILLIAM J HILLEGAS
Correspondent
Solohill Engineering, Inc.
323 E. William, Suite 44
Ann Arbor,  MI  48104
Correspondent Contact WILLIAM J HILLEGAS
Regulation Number864.2240
Classification Product Code
KJB  
Date Received06/12/1985
Decision Date 07/12/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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