CIDEX OPA SOLUTION (0.55% ORTHRO-PHTHALALDEHYDE SOLUTION)


the company

Device Classification Name

sterilant, medical devices

510(k) Number K002401
Device Name CIDEX OPA SOLUTION (0.55% ORTHRO-PHTHALALDEHYDE SOLUTION)
Original Applicant
ADVANCED STERILIZATION PRODUCTS
33 technology dr.
irvine, 
CA 
92618

Original Contact neelu medheker
Regulation Number 880.6885
Classification Product Code
MED  
Date Received 08/07/2000
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

Recalls CDRH Recalls