Richards Intra-Articular Shaver Motor
FDA 510(k) K842475 · Richards Medical Co., Inc.
510(k) numberK842475
Submission
- Device name
- Richards Intra-Articular Shaver Motor
- Applicant
- Richards Medical Co., Inc.
Mchenry, IL, US - Received
- June 25, 1984
- Decision date
- September 17, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GEY – Motor, Surgical Instrument, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Specialty
- General, Plastic Surgery
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Questions and answers
When was Richards Intra-Articular Shaver Motor cleared by the FDA?
Richards Intra-Articular Shaver Motor (K842475) received a 510(k) decision of Substantially Equivalent on September 17, 1984, 84 days after the submission was received.
What is the product code of K842475?
The FDA product code is GEY – Motor, Surgical Instrument, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 878.4820.