The following data is part of a premarket notification filed by Deroyal Industries, Inc. with the FDA for Deroyal Industries Disposable Surgical Trocar/cannula.
| Device ID | K974763 |
| 510k Number | K974763 |
| Device Name: | DEROYAL INDUSTRIES DISPOSABLE SURGICAL TROCAR/CANNULA |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849 |
| Contact | Camille Mattlock |
| Correspondent | Camille Mattlock DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-19 |
| Decision Date | 1998-07-10 |
| Summary: | summary |