The following data is part of a premarket notification filed by Bioplexus Corp. with the FDA for Biosil Medical Grade Silicone Sheeting.
| Device ID | K932176 |
| 510k Number | K932176 |
| Device Name: | BIOSIL MEDICAL GRADE SILICONE SHEETING |
| Classification | Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) |
| Applicant | BIOPLEXUS CORP. 3753 HOWARD HUGHES PKWY. SUITE 310 Las Vegas, NV 89109 |
| Contact | Eschbach |
| Correspondent | Eschbach BIOPLEXUS CORP. 3753 HOWARD HUGHES PKWY. SUITE 310 Las Vegas, NV 89109 |
| Product Code | KHJ |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-05 |
| Decision Date | 1993-12-02 |