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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 K871324
Device Name DU PONT STERICELL CELL CULTURE SYSTEM
Applicant
E.I. Dupont DE Nemours & Co., Inc.
Medical Products Dept.
Barley Mill Plz., P22-1170
Wilmington,  DE  19898
Applicant Contact GRACE H SINGLES
Correspondent
E.I. Dupont DE Nemours & Co., Inc.
Medical Products Dept.
Barley Mill Plz., P22-1170
Wilmington,  DE  19898
Correspondent Contact GRACE H SINGLES
Regulation Number864.2240
Classification Product Code
KJA  
Date Received04/03/1987
Decision Date 04/14/1987
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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