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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 K861253
Device Name TISSUE CULTURE FLASK PL 732 PLASTIC
Applicant
Travenol Laboratories, S.A.
Deerfield,  IL  60015
Applicant Contact LAKE, PHD
Correspondent
Travenol Laboratories, S.A.
Deerfield,  IL  60015
Correspondent Contact LAKE, PHD
Regulation Number864.2240
Classification Product Code
KJA  
Date Received04/03/1986
Decision Date 04/11/1986
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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