The following data is part of a premarket notification filed by National Medical Devices, Inc. with the FDA for Silicone Block.
| Device ID | K042380 |
| 510k Number | K042380 |
| Device Name: | SILICONE BLOCK |
| Classification | Elastomer, Silicone Block |
| Applicant | NATIONAL MEDICAL DEVICES, INC. 8500 WILSHIRE BLVD. SUITE 707 Beverly Hills, CA 90211 |
| Contact | James Elist |
| Correspondent | James Elist NATIONAL MEDICAL DEVICES, INC. 8500 WILSHIRE BLVD. SUITE 707 Beverly Hills, CA 90211 |
| Product Code | MIB |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-01 |
| Decision Date | 2004-10-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B097IMD001XXL1 | K042380 | 000 |
| B097IMD001XL1 | K042380 | 000 |
| B097IMD001L1 | K042380 | 000 |
| B097IMD006XXL1 | K042380 | 000 |
| B097IMD006XLO1 | K042380 | 000 |
| B097IMD006XL1 | K042380 | 000 |
| B097IMD006LLO1 | K042380 | 000 |
| B097IMD006L1 | K042380 | 000 |