The following data is part of a premarket notification filed by Pall Corp. with the FDA for Pall Supor Aef Filter.
Device ID | K993379 |
510k Number | K993379 |
Device Name: | PALL SUPOR AEF FILTER |
Classification | Filter, Infusion Line |
Applicant | PALL CORP. 2200 NORTHERN BLVD. East Hills, NY 11548 |
Contact | Leonard S Berman |
Correspondent | Leonard S Berman PALL CORP. 2200 NORTHERN BLVD. East Hills, NY 11548 |
Product Code | FPB |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-10-07 |
Decision Date | 1999-12-16 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
30636207315442 | K993379 | 000 |
30636207315435 | K993379 | 000 |
35034480308826 | K993379 | 000 |
35034480104374 | K993379 | 000 |