0.55% ORTH-PHTHALALDEHYDE SOLUTION


Device Classification Name

sterilant, medical devices

510(k) Number K030004
Device Name 0.55% ORTH-PHTHALALDEHYDE SOLUTION
Original Applicant
ADVANCED STERILIZATION PRODUCTS
33 technology dr.
irvine, 
CA 
92618

Original Contact neelu medhekar
Regulation Number 880.6885
Classification Product Code
MED  
Date Received 01/02/2003
Decision Date 02/27/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls