The following data is part of a premarket notification filed by Cook Urological, Inc. with the FDA for Cook Pediatric Flexor Ureteral Access Shealth.
| Device ID | K043418 |
| 510k Number | K043418 |
| Device Name: | COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH |
| Classification | Endoscopic Access Overtube, Gastroenterology-urology |
| Applicant | COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer, IN 47460 |
| Contact | Cindy Rumple |
| Correspondent | Cindy Rumple COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer, IN 47460 |
| Product Code | FED |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-13 |
| Decision Date | 2005-03-31 |
| Summary: | summary |