The following data is part of a premarket notification filed by Alpha Therapeutic Corp. with the FDA for Alpha Micron 20 Microaggregate Filter.
| Device ID | K955515 |
| 510k Number | K955515 |
| Device Name: | ALPHA MICRON 20 MICROAGGREGATE FILTER |
| Classification | Microfilter, Blood Transfusion |
| Applicant | ALPHA THERAPEUTIC CORP. 5555 VALLEY BLVD. Los Angeles, CA 90032 |
| Contact | M. Sue Preston |
| Correspondent | M. Sue Preston ALPHA THERAPEUTIC CORP. 5555 VALLEY BLVD. Los Angeles, CA 90032 |
| Product Code | CAK |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-04 |
| Decision Date | 1996-02-12 |