The following data is part of a premarket notification filed by Asahi Medical Co., Ltd. with the FDA for Modified Sepacell R-500 And R-500a Blood Filters.
| Device ID | K896976 |
| 510k Number | K896976 |
| Device Name: | MODIFIED SEPACELL R-500 AND R-500A BLOOD FILTERS |
| Classification | Microfilter, Blood Transfusion |
| Applicant | ASAHI MEDICAL CO., LTD. INTL. SQUARE 1825 EYE ST., N.W., SUITE 400 Washington, DC 20006 |
| Contact | Anderson |
| Correspondent | Anderson ASAHI MEDICAL CO., LTD. INTL. SQUARE 1825 EYE ST., N.W., SUITE 400 Washington, DC 20006 |
| Product Code | CAK |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-13 |
| Decision Date | 1990-01-24 |