The following data is part of a premarket notification filed by Gi Supply with the FDA for Bite Block/mouthpiece For Endoscopy.
| Device ID | K915816 |
| 510k Number | K915816 |
| Device Name: | BITE BLOCK/MOUTHPIECE FOR ENDOSCOPY |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | GI SUPPLY 423N. 21ST ST. Camp Hill, PA 17011 |
| Contact | Frank W Jackson |
| Correspondent | Frank W Jackson GI SUPPLY 423N. 21ST ST. Camp Hill, PA 17011 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-30 |
| Decision Date | 1992-03-27 |