The following data is part of a premarket notification filed by Vital Signs, Inc. with the FDA for Flex-elbow.
| Device ID | K912652 |
| 510k Number | K912652 |
| Device Name: | FLEX-ELBOW |
| Classification | Connector, Airway (extension) |
| Applicant | VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512 |
| Contact | Dennis Irlbeck |
| Correspondent | Dennis Irlbeck VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512 |
| Product Code | BZA |
| CFR Regulation Number | 868.5810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-17 |
| Decision Date | 1991-10-10 |