The following data is part of a premarket notification filed by Advanced Sterilization Products with the FDA for 0.55% Orth-phthalaldehyde Solution.
| Device ID | K030004 |
| 510k Number | K030004 |
| Device Name: | 0.55% ORTH-PHTHALALDEHYDE SOLUTION |
| Classification | Sterilant, Medical Devices |
| Applicant | ADVANCED STERILIZATION PRODUCTS 33 TECHNOLOGY DR. Irvine, CA 92618 |
| Contact | Neelu Medhekar |
| Correspondent | Neelu Medhekar ADVANCED STERILIZATION PRODUCTS 33 TECHNOLOGY DR. Irvine, CA 92618 |
| Product Code | MED |
| CFR Regulation Number | 880.6885 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-02 |
| Decision Date | 2003-02-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705037000071 | K030004 | 000 |