510(k) K991324
- Device
- TITANIUM VOCAL FOLD MEDIALIZING IMPLANT, MODELS 5001 001 (FEMALE), AND 5001 003 (MALE)
- Applicant
- HEINZ KURZ
- 510(k) number
- K991324
- Product code
- KHJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-05-18
- Date received
- 1999-04-19
- 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
Applicant Contact#
- Contact
- DAGMAR S MASER
- Address
- Tuebinger Strasse 3 Dusslingen DE D-72144 D-72144
FDA Registration Numbers#
- 3013840437
- 1416980
- 1045254
- 1000393132
- 3017636737
- 3009217531
- 3002806953
- 3009403363
- 3018094310
- 3006306415
- 2135225
- 1531062
- 3004450973
- 1048735
- 3003418325
- 1928237
- 3011050570
- 3002807315
- 9612501
- 1037007
- 1835959
- 3014334038
- 1052728
- 3003790304
Source Documents#
Other 510(k) Records For Product Code KHJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K232646 | Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9) | Cook Biotech Incorporated | 2024-05-24 |
| K161000 | Biodesign Otologic Repair Graft | Cook Biotech Incorporated | 2016-05-11 |
| K150594 | Biodesign Otologic Repair Graft | Cook Biotech Incorprated | 2015-09-16 |
| K132198 | ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI | Ceremed , Inc. | 2013-09-12 |
| K121360 | BIODESIGN ENT REPAIR GRAFT | Cook Biotech Incorprated | 2013-02-27 |
| K122561 | ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN | Ceremed , Inc. | 2012-11-27 |
| K120220 | ADAPTAIN SOLUBLE IMPLANT MATERIAL | Ceremed , Inc. | 2012-06-06 |
| K103047 | CERETENE SOLUBLE IMPLANT MATERIAL | Ceremed , Inc. | 2011-01-05 |
| K080022 | GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP | Vascular Solutions, Inc. | 2008-12-09 |
| K082245 | AOC, OSTENE, AOC IMPLANT MATERIAL, CERETENE, OSTENE LUBE, AOC-LV | Ceremed , Inc. | 2008-09-18 |
| K081531 | AOC SOLUBLE IMPLANT MATERIAL | Ceremed , Inc. | 2008-07-18 |
| K070093 | OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE, ACTIPASTE | Ceremed , Inc. | 2007-01-24 |
| K062280 | OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE AND ACTIPASTE | Ceremed , Inc. | 2006-12-11 |
| K060561 | CLEARADEX GEL | Cambridgemed | 2006-05-30 |
| K060878 | GELITA-SPON ABSORBABLE GELATIN SPONGE, USP | Curamedical, BV | 2006-04-13 |
Legacy Summary#
summary
FDA Review#
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