Vocom Implant- 8MM
FDA 510(k) K000533 · Smith & Nephew, Inc.
510(k) numberK000533
Submission
- Device name
- Vocom Implant- 8MM
- Applicant
- Smith & Nephew, Inc.
Bartlett, TN, US - Received
- February 17, 2000
- Decision date
- March 1, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MIX – System, Vocal Cord Medialization
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3620
- Specialty
- Ear, Nose, Throat
- Implant
- Yes
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| K121795 | Calcium Hydroxylapatite Vocal Fold ImplantMIX · Traditional | Cytophil, Inc. | 02/22/2013SE |
| K083783 | VF LiquigelMIX · Traditional | Coapt Systems, Inc. | 09/11/2009SE |
| K081816 | Vocalis and Vocalis SMMIX · Traditional | Cytophil, Inc. | 01/05/2009SE |
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| K080956 | Modification to VF Gel PlusMIX · Special | Coapt Systems, Inc. | 04/25/2008SE |
| K071663 | VF Gel PlusMIX · Traditional | Coapt Systems, Inc. | 02/15/2008SE |
| K070090 | Radiesse Laryngeal ImplantMIX · Special | Bioform Medical, Inc. | 03/01/2007SE |
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Questions and answers
When was Vocom Implant- 8MM cleared by the FDA?
Vocom Implant- 8MM (K000533) received a 510(k) decision of Substantially Equivalent on March 1, 2000, 13 days after the submission was received.
What is the product code of K000533?
The FDA product code is MIX – System, Vocal Cord Medialization, a Class II (moderate risk) device regulated under 21 CFR 874.3620.