The following data is part of a premarket notification filed by United States Endoscopy Group, Inc. with the FDA for Bio Guard Air/water & Suction Valves.
| Device ID | K192059 |
| 510k Number | K192059 |
| Device Name: | Bio Guard Air/Water & Suction Valves |
| Classification | Endoscope Channel Accessory |
| Applicant | United States Endoscopy Group, Inc. 5976 Heisley Road Mentor, OH 44060 |
| Contact | Carroll Martin |
| Correspondent | Carroll Martin United States Endoscopy Group, Inc. 5976 Heisley Road Mentor, OH 44060 |
| Product Code | ODC |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-01 |
| Decision Date | 2019-09-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10816765012779 | K192059 | 000 |
| 10724995180536 | K192059 | 000 |