The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Xomed Silicone Block/strip.
| Device ID | K970910 |
| 510k Number | K970910 |
| Device Name: | XOMED SILICONE BLOCK/STRIP |
| Classification | Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) |
| Applicant | XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 -0980 |
| Contact | David Timlin |
| Correspondent | David Timlin 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 | 1997-03-12 |
| Decision Date | 1997-05-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20681490042455 | K970910 | 000 |
| 20681490042424 | K970910 | 000 |
| 20763000040257 | K970910 | 000 |
| 20763000040233 | K970910 | 000 |
| 20763000040219 | K970910 | 000 |
| 20681490042431 | K970910 | 000 |
| 20763000040226 | K970910 | 000 |
| 20681490042448 | K970910 | 000 |
| 20763000040240 | K970910 | 000 |