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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Flask, Tissue Culture
510(k) Number K853441
Device Name FETAL BOVINE SERUM IN TRANSFER CONTAINER
Applicant
Newport Biosystems, Inc.
Rod Roberts
150 E. Edinger, Suite C
Santa Ana,  CA  92705
Applicant Contact CULT INNOV
Correspondent
Newport Biosystems, Inc.
Rod Roberts
150 E. Edinger, Suite C
Santa Ana,  CA  92705
Correspondent Contact CULT INNOV
Regulation Number864.2240
Classification Product Code
KJA  
Date Received08/13/1985
Decision Date 08/26/1985
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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