FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
TITANIUM VOCAL FOLD MEDIALIZING IMPLANT, MODELS 5001 001 (FEMALE), AND 5001 003 (MALE)
K Number: K991324
·
Decision May 18, 1999
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
32
Applicant Total
5
Review Days
29
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Basic Information
- Device Name
- TITANIUM VOCAL FOLD MEDIALIZING IMPLANT, MODELS 5001 001 (FEMALE), AND 5001 003 (MALE)
- K Number
- K991324
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3620
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Heinz Kurz
- Date Received
- April 19, 1999
- Decision Date
- May 18, 1999
- Product Code
- KHJ
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KHJ | Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
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Other Clearances by Heinz Kurz
| K Number | Device Name | ||
|---|---|---|---|
| K010442 | KURZ ANGULAR PISTON-TITANIUM PROSTHESIS, MODELS 1006 600, 1006 601, 1006 602, 1006 650, 1006 651, 1006 652 | Mar 8, 2001 | Substantially Equivalent |
| K990923 | TUBINGEN TITANIUM PROSTHESIS (TTP) VARIO, MODELS AERIAL 1004 010 & BELL 1002 010 | Mar 31, 1999 | Substantially Equivalent |
| K973356 | K-PISTON WITH BAND HOOK /ANGULAR PISTON | Nov 21, 1997 | Substantially Equivalent |
| K972492 | BELL PROSTHESIS (PARTIAL) | Aug 4, 1997 | Substantially Equivalent |