Creat Brand Wagner Chin Implant
FDA 510(k) K812210 · Aesthetech Corp.
510(k) numberK812210
Submission
- Device name
- Creat Brand Wagner Chin Implant
- Applicant
- Aesthetech Corp.
Mchenry, IL, US - Received
- August 4, 1981
- Decision date
- September 11, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FWP – Prosthesis, Chin, Internal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3550
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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| K873940 | Creat Brand O-Rise General AspiratorBTA · Traditional | 11/25/1987SE |
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| K853189 | Creat Brand I/A Pack Creat Brand Phaco PackHQC · Traditional | 09/24/1985SE |
| K843678 | Creat Brand Skin ExpanderLCJ · Traditional | 11/06/1984SE |
| K841283 | Disposable Suction Tubing Set · Traditional | 04/24/1984SE |
Questions and answers
When was Creat Brand Wagner Chin Implant cleared by the FDA?
Creat Brand Wagner Chin Implant (K812210) received a 510(k) decision of Substantially Equivalent on September 11, 1981, 38 days after the submission was received.
What is the product code of K812210?
The FDA product code is FWP – Prosthesis, Chin, Internal, a Class II (moderate risk) device regulated under 21 CFR 878.3550.