The following data is part of a premarket notification filed by United States Endoscopy Group, Inc. with the FDA for Bioguard Air/water Valve, Bioguard Suction Valve.
| Device ID | K151345 |
| 510k Number | K151345 |
| Device Name: | BioGuard Air/Water Valve, BioGuard Suction Valve |
| Classification | Endoscope Channel Accessory |
| Applicant | UNITED STATES ENDOSCOPY GROUP, INC. 5976 HEISLEY ROAD Mentor, OH 44060 |
| Contact | Carroll L. Martin |
| Correspondent | Carroll L. 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-19 |
| Decision Date | 2015-08-25 |