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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 K864021
Device Name TISSUE CULTURE FLASK
Applicant
Fenwal Laboratories
Division Of Travenol Labs
Round Lake,  IL  60073
Applicant Contact JOHN BRDA
Correspondent
Fenwal Laboratories
Division Of Travenol Labs
Round Lake,  IL  60073
Correspondent Contact JOHN BRDA
Regulation Number864.2240
Classification Product Code
KJA  
Date Received10/15/1986
Decision Date 10/29/1986
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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