The following data is part of a premarket notification filed by Advanced Sterilization Products with the FDA for Sterrad Chemial Indicator Strip Model 14100.
Device ID | K111518 |
510k Number | K111518 |
Device Name: | STERRAD CHEMIAL INDICATOR STRIP MODEL 14100 |
Classification | Indicator, Physical/chemical Sterilization Process |
Applicant | ADVANCED STERILIZATION PRODUCTS 33 TECHNOLOGY DR. Irvine, CA 92618 |
Contact | Nancy Chu |
Correspondent | Nancy Chu ADVANCED STERILIZATION PRODUCTS 33 TECHNOLOGY DR. Irvine, CA 92618 |
Product Code | JOJ |
CFR Regulation Number | 880.2800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-06-02 |
Decision Date | 2012-10-03 |
Summary: | summary |