510(k) K982294
- Device
- XOMED SILICONE PRE-FORM BLOCKS
- Applicant
- XOMED, INC.
- 510(k) number
- K982294
- Product code
- KHJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-09-18
- Date received
- 1998-06-30
- Regulation
- 874.3620
- Classification name
- Polymer, Ent Synthetic-polyamide (mesh Or Foil Material)
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- ROY BERENS
- Address
- 6743 Southpoint Dr. N. Jacksonville FL US 32216 32216
FDA Registration Numbers
- 3017636737
- 1045254
- 1048735
- 1416980
- 3003790304
- 3002807315
- 1052728
- 3013840437
- 3014334038
- 3002806953
- 9612501
- 2135225
- 1835959
- 3009217531
- 3006306415
- 1531062
- 3011050570
- 3004450973
- 1928237
- 1000393132
- 1037007
- 3018094310
- 3003418325
- 3009403363
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Legacy Summary
summary
FDA Review
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