Pro-Tip Disposable 3/1 Syringe Nozzle
FDA 510(k) K923285 · Smith & Nephew, Inc.
510(k) numberK923285
Submission
- Device name
- Pro-Tip Disposable 3/1 Syringe Nozzle
- Applicant
- Smith & Nephew, Inc.
Franklin Park, IL, US - Received
- July 6, 1992
- Decision date
- September 15, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K923876 | Riskontrol Single UseECB · Traditional | Riskontrol | 04/05/1993SE |
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| K890290 | Brace (Orafix Special)ECB · Traditional | Norcliff Thayer, Inc. | 03/29/1989SE |
| K863024 | Seringa Triplice S.L.ECB · Traditional | Sds Dental, Inc. | 09/25/1986SE |
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Questions and answers
When was Pro-Tip Disposable 3/1 Syringe Nozzle cleared by the FDA?
Pro-Tip Disposable 3/1 Syringe Nozzle (K923285) received a 510(k) decision of Substantially Equivalent on September 15, 1992, 71 days after the submission was received.
What is the product code of K923285?
The FDA product code is ECB – Unit, Syringe, Air And/Or Water, a Class I (low risk) device regulated under 21 CFR 872.4565.