The following data is part of a premarket notification filed by Critikon Company,llc with the FDA for Critikon 48-hour Air Eliminating Filter.
Device ID | K861644 |
510k Number | K861644 |
Device Name: | CRITIKON 48-HOUR AIR ELIMINATING FILTER |
Classification | Filter, Infusion Line |
Applicant | CRITIKON COMPANY,LLC 4110 GEORGE RD. P.O. BOX 22800 Tampa, FL 33630 |
Contact | Melanie Sabo |
Correspondent | Melanie Sabo CRITIKON COMPANY,LLC 4110 GEORGE RD. P.O. BOX 22800 Tampa, FL 33630 |
Product Code | FPB |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-04-30 |
Decision Date | 1986-07-22 |