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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator, Physical/Chemical Sterilization Process
510(k) Number K921910
Device Name STERRAD CHEMICAL INDICATOR
Applicant
Johnson & Johnson Medical, Inc.
P.O. Box 90130
Arlington,  TX  76004
Applicant Contact WENDT
Correspondent
Johnson & Johnson Medical, Inc.
P.O. Box 90130
Arlington,  TX  76004
Correspondent Contact WENDT
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received04/23/1992
Decision Date 10/04/1993
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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