Novo Vivo Model #17140 and #17135
FDA 510(k) K880377 · Genesis Industries, Inc.
510(k) numberK880377
Submission
- Device name
- Novo Vivo Model #17140 and #17135
- Applicant
- Genesis Industries, Inc.
Spring Valley, WI, US - Received
- January 27, 1988
- Decision date
- April 4, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GAA – Needle, Aspiration And Injection, Disposable
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
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| K833290 | C & B 40 Pentro C & B40EIS · Traditional | 01/03/1984SE |
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| K833289 | C & B 61 Pentron C & B61EIS · Traditional | 12/29/1983SE |
| K833278 | C & B 45EIS · Traditional | 12/29/1983SE |
| K833280 | Supra Ap Choice 83EIS · Traditional | 12/26/1983SE |
| K833285 | RX IV Pentron IVEIS · Traditional | 12/22/1983SE |
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Questions and answers
When was Novo Vivo Model #17140 and #17135 cleared by the FDA?
Novo Vivo Model #17140 and #17135 (K880377) received a 510(k) decision of Substantially Equivalent on April 4, 1988, 68 days after the submission was received.
What is the product code of K880377?
The FDA product code is GAA – Needle, Aspiration And Injection, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.