The following data is part of a premarket notification filed by Meditera Tibbi Malzeme San. Ve Tic. A.s. with the FDA for Altera Filter And Hme/filter.
| Device ID | K192713 |
| 510k Number | K192713 |
| Device Name: | Altera Filter And HME/Filter |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | Meditera Tibbi Malzeme San. Ve Tic. A.S. Ibni Melek OSB Mah. TOSBI Yol 4 Sok No: 29 Tire Organize Sanayi Bolgesi, Tire Izmir, TR 35900 |
| Contact | Cenk Kilic Kalkan |
| Correspondent | Paul Dryden Meditera Tibbi Malzeme San. Ve Tic. A.S. % ProMedic, LLC 131 Bay Point Dr NE St. Petersburg, FL 33704 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-27 |
| Decision Date | 2020-03-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840117305878 | K192713 | 000 |
| 00840117305854 | K192713 | 000 |
| M485AL08021V0012 | K192713 | 000 |
| M4853116128 | K192713 | 000 |
| 10850014574687 | K192713 | 000 |
| 10850014574670 | K192713 | 000 |
| 10850014574663 | K192713 | 000 |