The following data is part of a premarket notification filed by Advanced Sterilization Products with the FDA for Tyvek Self-seal Pouches ,tyvek Heat-seal Rolls.
| Device ID | K112087 |
| 510k Number | K112087 |
| Device Name: | TYVEK SELF-SEAL POUCHES ,TYVEK HEAT-SEAL ROLLS |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| 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 | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-21 |
| Decision Date | 2012-10-15 |
| Summary: | summary |