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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 K002401
Device Name CIDEX OPA SOLUTION (0.55% ORTHRO-PHTHALALDEHYDE SOLUTION)
Applicant
ADVANCED STERILIZATION PRODUCTS
33 TECHNOLOGY DR.
IRVINE,  CA  92618
Applicant Contact NEELU MEDHEKER
Correspondent
ADVANCED STERILIZATION PRODUCTS
33 TECHNOLOGY DR.
IRVINE,  CA  92618
Correspondent Contact NEELU MEDHEKER
Regulation Number880.6885
Classification Product Code
MED  
Date Received08/07/2000
Decision Date 08/29/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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