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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilant, Medical Devices
510(k) Number K924334
Device Name CIDEX FORMULA 7* LONG-LIFE ACTIVATED DIALDEHYDE
Applicant
Johnson & Johnson Medical, Inc.
P.O. Box 90130
Arlington,  TX  76004
Applicant Contact T. M WENFT
Correspondent
Johnson & Johnson Medical, Inc.
P.O. Box 90130
Arlington,  TX  76004
Correspondent Contact T. M WENFT
Regulation Number880.6885
Classification Product Code
MED  
Date Received08/27/1992
Decision Date 03/29/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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