The following data is part of a premarket notification filed by Dexide, Inc. with the FDA for Monoscopy(tm) Brand, Trocar Reducer Set.
| Device ID | K902563 |
| 510k Number | K902563 |
| Device Name: | MONOSCOPY(TM) BRAND, TROCAR REDUCER SET |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| 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 | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-11 |
| Decision Date | 1990-09-04 |