The following data is part of a premarket notification filed by Byron Medical with the FDA for Zara Silicone Block.
| Device ID | K913882 |
| 510k Number | K913882 |
| Device Name: | ZARA SILICONE BLOCK |
| Classification | Elastomer, Silicone Block |
| Applicant | BYRON MEDICAL 3280 E. HEMISPHERE LOOP SUITE 100 Tucson, AZ 85706 |
| Contact | Byron G Economidy |
| Correspondent | Byron G Economidy BYRON MEDICAL 3280 E. HEMISPHERE LOOP SUITE 100 Tucson, AZ 85706 |
| Product Code | MIB |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-29 |
| Decision Date | 1992-04-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M724BLKBSC51 | K913882 | 000 |
| M724BL20OM1 | K913882 | 000 |
| M724BL20OS1 | K913882 | 000 |
| M724BLK10NS1 | K913882 | 000 |
| M724BLK20NS1 | K913882 | 000 |
| M724BLK40NS1 | K913882 | 000 |
| M724BLK201 | K913882 | 000 |
| M724BLK101 | K913882 | 000 |
| M724BLKBSC11 | K913882 | 000 |
| M724BLKBSC21 | K913882 | 000 |
| M724BLKBSC31 | K913882 | 000 |
| M724BLKBSC41 | K913882 | 000 |
| M724BL20OF1 | K913882 | 000 |