The following data is part of a premarket notification filed by Pall Biomedical Products Co. with the FDA for Pall Sq40s Blood Filter (sq40s/sq40st).
| Device ID | K960993 |
| 510k Number | K960993 |
| Device Name: | PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST) |
| Classification | Microfilter, Blood Transfusion |
| Applicant | PALL BIOMEDICAL PRODUCTS CO. 2200 NORTHERN BLVD. East Hills, NY 11548 |
| Contact | Robert A Dickstein, Ph.d. |
| Correspondent | Robert A Dickstein, Ph.d. PALL BIOMEDICAL PRODUCTS CO. 2200 NORTHERN BLVD. East Hills, NY 11548 |
| Product Code | CAK |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-12 |
| Decision Date | 1996-04-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30887691001247 | K960993 | 000 |
| 30887691000684 | K960993 | 000 |
| 30887691000677 | K960993 | 000 |
| 30887691000660 | K960993 | 000 |