The following data is part of a premarket notification filed by Deroyal Industries, Inc. with the FDA for Deroyal Laprador Specimen Retrieval System.
| Device ID | K171475 |
| 510k Number | K171475 |
| Device Name: | DeRoyal Laprador Specimen Retrieval System |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | DeRoyal Industries, Inc. 200 DeBusk Lane Powell, TN 37849 |
| Contact | Sarah Bennett |
| Correspondent | Sarah Bennett DeRoyal Industries, Inc. 200 DeBusk Lane Powell, TN 37849 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-19 |
| Decision Date | 2017-08-17 |
| Summary: | summary |