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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Formulations, Balanced Salt Solutions
510(k) Number K860784
Device Name DULBECCO'S PHOSPHATE BUFFERED SALINE W/CALCL2
Applicant
Tissue Culture Innovations
1580 E. Edinger, Suite C
Santa Ana,  CA  92705
Applicant Contact ROD ROBERTS
Correspondent
Tissue Culture Innovations
1580 E. Edinger, Suite C
Santa Ana,  CA  92705
Correspondent Contact ROD ROBERTS
Regulation Number864.2875
Classification Product Code
KIP  
Date Received03/03/1986
Decision Date 03/12/1986
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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