The following data is part of a premarket notification filed by Dexide, Inc. with the FDA for Monoscopy Brand, 5 Mm Locking Trocar Sleeve.
| Device ID | K896205 |
| 510k Number | K896205 |
| Device Name: | MONOSCOPY BRAND, 5 MM LOCKING TROCAR SLEEVE |
| Classification | Laryngoscope, Endoscope |
| Applicant | DEXIDE, INC. P.O. BOX 185789 Ft. Worth, TX 76181 |
| Contact | Miller, R.n. |
| Correspondent | Miller, R.n. DEXIDE, INC. P.O. BOX 185789 Ft. Worth, TX 76181 |
| Product Code | GCI |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-26 |
| Decision Date | 1990-03-22 |