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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 K880509
Device Name MULTISURFACE ROLLER BOTTLE (M.S.R.B.)
Applicant
Motil Plastics , Ltd.
Pengam Rd. Industrial Estate
Aberbargoed
Bargoed Mid Glamorga,  GB CF8 9FW
Applicant Contact JUDY RIDLER
Correspondent
Motil Plastics , Ltd.
Pengam Rd. Industrial Estate
Aberbargoed
Bargoed Mid Glamorga,  GB CF8 9FW
Correspondent Contact JUDY RIDLER
Regulation Number864.2240
Classification Product Code
KJC  
Date Received02/10/1988
Decision Date 04/01/1988
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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