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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Support Gels
510(k) Number K940037
Device Name I.D. AND SEAKEM GTG AGAROSES
Applicant
Fmc Corp.
1001 G St., NW
Sutie 500 W.
Washington,  DC  20001
Applicant Contact MELVIN S DROZEN
Correspondent
Fmc Corp.
1001 G St., NW
Sutie 500 W.
Washington,  DC  20001
Correspondent Contact MELVIN S DROZEN
Regulation Number866.4900
Classification Product Code
JZR  
Date Received01/04/1994
Decision Date 02/24/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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