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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, High Pressure Liquid Chromatography
510(k) Number K911299
Device Name EQUIPMENT/MATERIAL DECONTAMINATING KIT
Applicant
Rohm and Haas Co.
C/O Kleinfeld, Kaplan & Becker
1140 Nineteenth St., NW
Washington,  DC  20036
Applicant Contact PETER O SAFIR
Correspondent
Rohm and Haas Co.
C/O Kleinfeld, Kaplan & Becker
1140 Nineteenth St., NW
Washington,  DC  20036
Correspondent Contact PETER O SAFIR
Regulation Number862.2260
Classification Product Code
KIE  
Date Received03/25/1991
Decision Date 04/08/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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