Osteo-Mesh Cranial Fairing
FDA 510(k) K860491 · Xomed, Inc.
510(k) numberK860491
Submission
- Device name
- Osteo-Mesh Cranial Fairing
- Applicant
- Xomed, Inc.
Jacksonville, FL, US - Received
- February 10, 1986
- Decision date
- March 28, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
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|---|---|---|
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| K002897 | Titanium Middle Ear ProsthesesETB · Traditional | 10/11/2000SE |
| K993653 | Micro-France Trocars and AccessoriesHET · Traditional | 06/09/2000SE |
| K001148 | Merogel Otologic PackKHJ · Traditional | 06/03/2000SE |
| K994262 | Frontal Sinus Trephination CannulaKAM · Traditional | 02/08/2000SE |
| K992855 | XPS Straightshot or Model 2000 Microdebrider System or XPS PowersculptQPB · Traditional | 01/21/2000SE |
| K993582 | Modification to Laser-Shield IIBTR · Traditional | 01/20/2000SE |
| K993655 | Micro-France Electrosurgical Instruments, VariousGEI · Traditional | 12/21/1999SE |
Questions and answers
When was Osteo-Mesh Cranial Fairing cleared by the FDA?
Osteo-Mesh Cranial Fairing (K860491) received a 510(k) decision of Substantially Equivalent on March 28, 1986, 46 days after the submission was received.