The following data is part of a premarket notification filed by Schoelly Fiberoptic Gmbh with the FDA for Schoelly Cystoscopes/hysteroscopes And Accessories.
| Device ID | K150158 |
| 510k Number | K150158 |
| Device Name: | Schoelly Cystoscopes/Hysteroscopes And Accessories |
| Classification | Hysteroscope (and Accessories) |
| Applicant | Schoelly Fiberoptic GmbH Robert-Bosch-Str. 1-3 Denzlingen, DE 79211 |
| Contact | Sandra Baumann |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2015-01-23 |
| Decision Date | 2015-03-09 |
| Summary: | summary |