The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Xomed Silicone Pre-form Blocks.
| Device ID | K982294 |
| 510k Number | K982294 |
| Device Name: | XOMED SILICONE PRE-FORM BLOCKS |
| Classification | Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) |
| Applicant | XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 -0980 |
| Contact | Roy Berens |
| Correspondent | Roy Berens XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 -0980 |
| Product Code | KHJ |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-30 |
| Decision Date | 1998-09-18 |
| Summary: | summary |