The following data is part of a premarket notification filed by Laserscope with the FDA for Laserscope Guided Delivery Device (gdd) Cystourethroscope & Accessories.
| Device ID | K061646 |
| 510k Number | K061646 |
| Device Name: | LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIES |
| Classification | Cystourethroscope |
| Applicant | LASERSCOPE 3070 ORCHARD DR. San Jose, CA 95134 -2011 |
| Contact | Paul Hardiman |
| Correspondent | Patricia L Murphy KEMA QUALITY B.V. 4377 COUNTY LINE ROAD Chalfont, PA 18914 |
| Product Code | FBO |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-06-12 |
| Decision Date | 2006-06-27 |
| Summary: | summary |