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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Bottle, Roller, Tissue Culture
510(k) Number K873137
Device Name IN VITRO 2.5X ROLLER BOTTLE
Applicant
In Vitro Scientific Products
2350 Valley Meadow Dr.
Oak View,  CA  93022
Applicant Contact JONATHAN M SERKES
Correspondent
In Vitro Scientific Products
2350 Valley Meadow Dr.
Oak View,  CA  93022
Correspondent Contact JONATHAN M SERKES
Regulation Number864.2240
Classification Product Code
KJC  
Date Received08/10/1987
Decision Date 08/24/1987
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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