Pab Convenience Tray
FDA 510(k) K781264 · Waters Assoc., Inc.
510(k) numberK781264
Submission
- Device name
- Pab Convenience Tray
- Applicant
- Waters Assoc., Inc.
Mchenry, IL, US - Received
- July 24, 1978
- Decision date
- September 20, 1978
- 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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| K791661 | System Controller 720 SeriesKIE · Traditional | 09/24/1979SE |
| K791026 | 4F Sterile Balloon-Less, Catheter 913-28KRB · Traditional | 06/22/1979SE |
| K790145 | Solvent Delivery SystemKIE · Traditional | 02/15/1979SE |
| K782175 | Cartridge Holder, RCM 100KIE · Traditional | 02/15/1979SE |
| K781805 | Cardiac Computers, CO-10 & CO-10RDXG · Traditional | 01/29/1979SE |
| K781915 | Data ModuleKIE · Traditional | 01/10/1979SE |
Questions and answers
When was Pab Convenience Tray cleared by the FDA?
Pab Convenience Tray (K781264) received a 510(k) decision of Substantially Equivalent on September 20, 1978, 58 days after the submission was received.
What is the product code of K781264?
The FDA product code is GAA – Needle, Aspiration And Injection, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.