The following data is part of a premarket notification filed by Advanced Sterilization Products with the FDA for Modification To Sterrad Sealsure Chemical Indicator Tape.
| Device ID | K040742 |
| 510k Number | K040742 |
| Device Name: | MODIFICATION TO STERRAD SEALSURE CHEMICAL INDICATOR TAPE |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | ADVANCED STERILIZATION PRODUCTS 33 TECHNOLOGY DR. Irvine, CA 92618 |
| Contact | Kevin Corrigan |
| Correspondent | Kevin Corrigan ADVANCED STERILIZATION PRODUCTS 33 TECHNOLOGY DR. Irvine, CA 92618 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-23 |
| Decision Date | 2004-04-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705037016201 | K040742 | 000 |
| 20705037067258 | K040742 | 000 |