The following data is part of a premarket notification filed by Bioplexus Corp. with the FDA for Medical Grade Silicone Block.
| Device ID | K952732 |
| 510k Number | K952732 |
| Device Name: | MEDICAL GRADE SILICONE BLOCK |
| Classification | Elastomer, Silicone Block |
| Applicant | BIOPLEXUS CORP. 3753 HOWARD HUGHES PKWY., SUITE 310 Las Vegas, NV 89109 |
| Contact | Jeff S Schleuning |
| Correspondent | Jeff S Schleuning BIOPLEXUS CORP. 3753 HOWARD HUGHES PKWY., SUITE 310 Las Vegas, NV 89109 |
| Product Code | MIB |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-15 |
| Decision Date | 1995-08-31 |