The following data is part of a premarket notification filed by Jayco Pharmaceuticals with the FDA for Endoscopic Manual Air Insufflator.
| Device ID | K844689 |
| 510k Number | K844689 |
| Device Name: | ENDOSCOPIC MANUAL AIR INSUFFLATOR |
| Classification | Insufflator, Automatic Carbon-dioxide For Endoscope |
| Applicant | JAYCO PHARMACEUTICALS 895 POPLAR CHURCH RD. Camp Hill, PA 17011 |
| Contact | Lester J Lifton |
| Correspondent | Lester J Lifton JAYCO PHARMACEUTICALS 895 POPLAR CHURCH RD. Camp Hill, PA 17011 |
| Product Code | FCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-03 |
| Decision Date | 1985-01-02 |