The following data is part of a premarket notification filed by Advanced Sterilization Products with the FDA for Sterrad Sterilization Pouch.
| Device ID | K951295 |
| 510k Number | K951295 |
| Device Name: | STERRAD STERILIZATION POUCH |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | ADVANCED STERILIZATION PRODUCTS 33 TECHNOLOGY DR. Irvine, CA 92618 |
| Contact | Pat Amtower |
| Correspondent | Pat Amtower 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 | 1995-03-22 |
| Decision Date | 1995-05-19 |