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 |