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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cells, Animal And Human, Cultured
510(k) Number K942820
Device Name H292
Applicant
Bartels, Inc.
2005 NW Sammamish Rd., #107
Issaquah,  WA  98027
Applicant Contact REBECCA D FULLER
Correspondent
Bartels, Inc.
2005 NW Sammamish Rd., #107
Issaquah,  WA  98027
Correspondent Contact REBECCA D FULLER
Regulation Number864.2280
Classification Product Code
KIR  
Date Received06/15/1994
Decision Date 05/05/1995
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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