The following data is part of a premarket notification filed by Dexide, Inc. with the FDA for Monoscopy Brand 5mm Lock Trocar Sleeve, Modified.
| Device ID | K912980 |
| 510k Number | K912980 |
| Device Name: | MONOSCOPY BRAND 5MM LOCK TROCAR SLEEVE, MODIFIED |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | DEXIDE, INC. P.O. BOX 185789 Ft. Worth, TX 76181 |
| Contact | Keith Jung |
| Correspondent | Keith Jung DEXIDE, INC. P.O. BOX 185789 Ft. Worth, TX 76181 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-24 |
| Decision Date | 1991-07-26 |