TYVEK SELF-SEAL POUCHES ,TYVEK HEAT-SEAL ROLLS


Device Classification Name

sterilization wrap containers, trays, cassettes & other accessories

510(k) Number K112087
Device Name TYVEK SELF-SEAL POUCHES ,TYVEK HEAT-SEAL ROLLS
Applicant
ADVANCED STERILIZATION PRODUCTS
33 technology dr.
irvine, 
CA 
92618

Applicant Contact nancy chu
Correspondent
ADVANCED STERILIZATION PRODUCTS
33 technology dr.
irvine, 
CA 
92618

Correspodent Contact nancy chu
Regulation Number 880.6850
Classification Product Code
KCT  
Subsequent Product Code
JOJ  
Date Received 07/21/2011
Decision Date 10/15/2012
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