Shea Cupped Torp with Hydroxylapatite Flange
FDA 510(k) K864444 · Richards Medical Co., Inc.
510(k) numberK864444
Submission
- Device name
- Shea Cupped Torp with Hydroxylapatite Flange
- Applicant
- Richards Medical Co., Inc.
Memphis, TN, US - Received
- November 12, 1986
- Decision date
- February 6, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- ETA – Replacement, Ossicular Prosthesis, Total
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3495
- Specialty
- Ear, Nose, Throat
- Implant
- Yes
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Questions and answers
When was Shea Cupped Torp with Hydroxylapatite Flange cleared by the FDA?
Shea Cupped Torp with Hydroxylapatite Flange (K864444) received a 510(k) decision of Substantially Equivalent on February 6, 1987, 86 days after the submission was received.
What is the product code of K864444?
The FDA product code is ETA – Replacement, Ossicular Prosthesis, Total, a Class II (moderate risk) device regulated under 21 CFR 874.3495.