The following data is part of a premarket notification filed by Bioplexus Corp. with the FDA for Biosil Medical Grade Silicone Sheeting For Obstetrical & Gynocology Applications.
| Device ID | K933827 |
| 510k Number | K933827 |
| Device Name: | BIOSIL MEDICAL GRADE SILICONE SHEETING FOR OBSTETRICAL & GYNOCOLOGY APPLICATIONS |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | BIOPLEXUS CORP. 3753 HOWARD HUGHES PKWY. SUITE 310 Las Vegas, NV 89109 |
| Contact | C.s. Eschbach |
| Correspondent | C.s. Eschbach BIOPLEXUS CORP. 3753 HOWARD HUGHES PKWY. SUITE 310 Las Vegas, NV 89109 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-05 |
| Decision Date | 1994-06-30 |