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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 K001381
Device Name CIDEX OPA SOLUTION
Applicant
ADVANCED STERILIZATION PRODUCTS
33 TECHNOLOGY DR.
IRVINE,  CA  92618
Applicant Contact NEELU MEDHEKAR
Correspondent
ADVANCED STERILIZATION PRODUCTS
33 TECHNOLOGY DR.
IRVINE,  CA  92618
Correspondent Contact NEELU MEDHEKAR
Regulation Number880.6885
Classification Product Code
MED  
Date Received05/02/2000
Decision Date 05/17/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Special
Reviewed by Third Party No
Combination Product No
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