The following data is part of a premarket notification filed by Medi-source, Inc. with the FDA for Berman Type Airway #59422-59429 Various Sizes.
| Device ID | K890566 |
| 510k Number | K890566 |
| Device Name: | BERMAN TYPE AIRWAY #59422-59429 VARIOUS SIZES |
| Classification | Airway, Oropharyngeal, Anesthesiology |
| Applicant | MEDI-SOURCE, INC. 50 GORDON DR. P.O. BOX 874 Syosset, NY 11791 |
| Contact | Andrew Galambos |
| Correspondent | Andrew Galambos MEDI-SOURCE, INC. 50 GORDON DR. P.O. BOX 874 Syosset, NY 11791 |
| Product Code | CAE |
| CFR Regulation Number | 868.5110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-06 |
| Decision Date | 1989-03-15 |