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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilizer, Ethylene-Oxide Gas
510(k) Number K915682
Device Name STERRAD 100 STERILIZATION SYSTEM
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 Number880.6860
Classification Product Code
FLF  
Date Received12/19/1991
Decision Date 10/01/1993
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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