510(k) K823261
- Device
- Interface Transfusion Blood Filter #30
- Applicant
- MEDICAL, INC.
- 510(k) number
- K823261
- Product code
- CAK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-01-07
- Date received
- 1982-11-02
- Regulation
- 880.5440
- Classification name
- Microfilter, Blood Transfusion
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3003775072
- 9612051
- 3014936217
- 3004548776
- 3017174574
- 9710488
- 2650143
- 1066733
- 3037389071
- 2029275
- 3004404323
- 1526534
- 1058584
- 3016844398
Source Documents#
510(k) summary PDF not indicated by FDA
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| K896664 | MODIFIED SEPACELL PL-SERIES LEUKOCYTE REMOVAL FILT | Asahi Medical Co., Ltd. | 1990-01-24 |
| K896976 | MODIFIED SEPACELL R-500 AND R-500A BLOOD FILTERS | Asahi Medical Co., Ltd. | 1990-01-24 |