Multiple Outlet Manifold
FDA 510(k) K850389 · The Anspach Effort, Inc.
510(k) numberK850389
Submission
- Device name
- Multiple Outlet Manifold
- Applicant
- The Anspach Effort, Inc.
Lake Park, FL, US - Received
- February 1, 1985
- Decision date
- March 18, 1985
- 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 Multiple Outlet Manifold cleared by the FDA?
Multiple Outlet Manifold (K850389) received a 510(k) decision of Substantially Equivalent on March 18, 1985, 45 days after the submission was received.
What is the product code of K850389?
The FDA product code is GEY – Motor, Surgical Instrument, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 878.4820.