The following data is part of a premarket notification filed by Cook Incorporated with the FDA for San Antonio Stopcock.
| Device ID | K181712 |
| 510k Number | K181712 |
| Device Name: | San Antonio Stopcock |
| Classification | Endoscope Channel Accessory |
| Applicant | Cook Incorporated 750 Daniels Way Bloomington, IN 47402 |
| Contact | James O. Ebot Rnaw |
| Correspondent | James O. Ebot Enaw Cook Incorporated 750 Daniels Way Bloomington, IN 47402 |
| Product Code | ODC |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-28 |
| Decision Date | 2018-07-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00827002173712 | K181712 | 000 |