The following data is part of a premarket notification filed by Advanced Sterilization Products with the FDA for Aptimax Instrument Tray, Instrument Mat And Instrument Holder.
| Device ID | K013003 |
| 510k Number | K013003 |
| Device Name: | APTIMAX INSTRUMENT TRAY, INSTRUMENT MAT AND INSTRUMENT HOLDER |
| Classification | Wrap, Sterilization |
| Applicant | ADVANCED STERILIZATION PRODUCTS 33 TECHNOLOGY DR. Irvine, CA 92618 |
| Contact | Natalie Bennington |
| Correspondent | Natalie Bennington 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 | 2001-09-06 |
| Decision Date | 2002-08-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705037016587 | K013003 | 000 |
| 20705037016089 | K013003 | 000 |
| 20705037016072 | K013003 | 000 |
| 20705037016065 | K013003 | 000 |
| 20705037016058 | K013003 | 000 |
| 20705037016041 | K013003 | 000 |
| 20705037016034 | K013003 | 000 |
| 20705037016027 | K013003 | 000 |
| 20705037016010 | K013003 | 000 |
| 20705037016096 | K013003 | 000 |
| 20705037016102 | K013003 | 000 |
| 10705037016525 | K013003 | 000 |
| 10705037016518 | K013003 | 000 |
| 20705037064486 | K013003 | 000 |
| 10705037048649 | K013003 | 000 |
| 10705037047611 | K013003 | 000 |
| 10705037016136 | K013003 | 000 |
| 20705037016126 | K013003 | 000 |
| 10705037016112 | K013003 | 000 |
| 10705037068173 | K013003 | 000 |