The following data is part of a premarket notification filed by United States Endoscopy Group, Inc. with the FDA for Aquashield System Co2, Aquashield System-pentax.
| Device ID | K153362 |
| 510k Number | K153362 |
| Device Name: | AquaShield System CO2, AquaShield System-PENTAX |
| Classification | Pump, Air, Non-manual, For Endoscope |
| 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 | FEQ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-20 |
| Decision Date | 2015-12-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10816765012984 | K153362 | 000 |