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 |