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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 -3130
Applicant Contact WENDT
Correspondent
JOHNSON & JOHNSON MEDICAL, INC.
P.O. BOX 90130
ARLINGTON,  TX  76004 -3130
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
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