The following data is part of a premarket notification filed by Coloplast A/s with the FDA for Orchestra Hydrophilic Guidewire Standard Angled, Orchestra Hydrophilic Guidewire Straight Stiff, Orchestra Hydrophilic Guidewire Angled Stiff,orchestra Hydrophilic Guidewire Standard Straight, Orchestra Hydrophilic Guidewire Straight Stiff.
| Device ID | K150927 |
| 510k Number | K150927 |
| Device Name: | Orchestra Hydrophilic Guidewire Standard Angled, Orchestra Hydrophilic Guidewire Straight Stiff, Orchestra Hydrophilic Guidewire Angled Stiff,Orchestra Hydrophilic Guidewire Standard Straight, Orchestra Hydrophilic Guidewire Straight Stiff |
| Classification | Endoscopic Guidewire, Gastroenterology-urology |
| Applicant | COLOPLAST A/S 1601 WEST RIVER ROAD NORTH Minneapolis, MN 55411 |
| Contact | Leeanne Swiridow |
| Correspondent | Leeanne Swiridow COLOPLAST A/S 1601 WEST RIVER ROAD NORTH Minneapolis, MN 55411 |
| Product Code | OCY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-06 |
| Decision Date | 2015-05-27 |
| Summary: | summary |