The following data is part of a premarket notification filed by American Cystocope Makers, Inc. with the FDA for Model Tx-8 Panendoscope.
| Device ID | K760822 |
| 510k Number | K760822 |
| Device Name: | MODEL TX-8 PANENDOSCOPE |
| Classification | Panendoscope (gastroduodenoscope) |
| Applicant | AMERICAN CYSTOCOPE MAKERS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FAK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-10-13 |
| Decision Date | 1976-10-21 |