The following data is part of a premarket notification filed by Advanced Sterilization Products with the FDA for Tyvek Self-seal Pouches With Sterrad, Tyvek Rolls With Sterrad, Tyvek Heat-seal With Sterrad Chemical Indicators.
| Device ID | K103210 |
| 510k Number | K103210 |
| Device Name: | TYVEK SELF-SEAL POUCHES WITH STERRAD, TYVEK ROLLS WITH STERRAD, TYVEK HEAT-SEAL WITH STERRAD CHEMICAL INDICATORS |
| Classification | Wrap, Sterilization |
| 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 | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-01 |
| Decision Date | 2011-06-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705037016570 | K103210 | 000 |
| 20705037015808 | K103210 | 000 |
| 20705037015792 | K103210 | 000 |
| 20705037015785 | K103210 | 000 |
| 20705037015778 | K103210 | 000 |
| 20705037015761 | K103210 | 000 |
| 20705037015754 | K103210 | 000 |
| 20705037015747 | K103210 | 000 |
| 20705037015730 | K103210 | 000 |
| 20705037015723 | K103210 | 000 |
| 20705037015815 | K103210 | 000 |
| 20705037015822 | K103210 | 000 |
| 20705037015938 | K103210 | 000 |
| 20705037015907 | K103210 | 000 |
| 20705037015891 | K103210 | 000 |
| 20705037015884 | K103210 | 000 |
| 20705037015877 | K103210 | 000 |
| 20705037015860 | K103210 | 000 |
| 20705037015853 | K103210 | 000 |
| 20705037015846 | K103210 | 000 |
| 20705037015839 | K103210 | 000 |
| 20705037015716 | K103210 | 000 |