The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Modification To Laser-shield Ii.
| Device ID | K993582 |
| 510k Number | K993582 |
| Device Name: | MODIFICATION TO LASER-SHIELD II |
| Classification | Tube, Tracheal (w/wo Connector) |
| 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 | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-22 |
| Decision Date | 2000-01-20 |
| Summary: | summary |