The following data is part of a premarket notification filed by King Systems Corp. with the FDA for Flex Blue.
| Device ID | K950318 |
| 510k Number | K950318 |
| Device Name: | FLEX BLUE |
| Classification | Device, Fixation, Tracheal Tube |
| Applicant | KING SYSTEMS CORP. 15011 HERRIMAN BLVD. P.O. BOX 1138 Noblesville, IN 46060 |
| Contact | Michael A Leagre |
| Correspondent | Michael A Leagre KING SYSTEMS CORP. 15011 HERRIMAN BLVD. P.O. BOX 1138 Noblesville, IN 46060 |
| Product Code | CBH |
| CFR Regulation Number | 868.5770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-26 |
| Decision Date | 1995-02-13 |