The following data is part of a premarket notification filed by Xylog Corp. with the FDA for Insufflator Filter Tubing Set.
| Device ID | K945970 |
| 510k Number | K945970 |
| Device Name: | INSUFFLATOR FILTER TUBING SET |
| Classification | Insufflator, Automatic Carbon-dioxide For Endoscope |
| Applicant | XYLOG CORP. 83 HOBART ST. Hackensack, NJ 07601 |
| Contact | Samuel Dickstein |
| Correspondent | Samuel Dickstein XYLOG CORP. 83 HOBART ST. Hackensack, NJ 07601 |
| Product Code | FCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-08 |
| Decision Date | 1994-12-15 |