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 |