Culdocentesis Tray
FDA 510(k) K780624 · Cutter Laboratories, Inc.
510(k) numberK780624
Submission
- Device name
- Culdocentesis Tray
- Applicant
- Cutter Laboratories, Inc.
Mchenry, IL, US - Received
- April 14, 1978
- Decision date
- May 26, 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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| K821326 | Cutter Bond Polycarboxylate CementEMA · Traditional | 05/28/1982SE |
| K813532 | Cutterbond Zinc Phosphate CementEMA · Traditional | 03/02/1982SE |
| K802105 | C-BladeHWE · Traditional | 09/16/1980SE |
| K802104 | C-SplintIQI · Traditional | 09/16/1980SE |
Questions and answers
When was Culdocentesis Tray cleared by the FDA?
Culdocentesis Tray (K780624) received a 510(k) decision of Substantially Equivalent on May 26, 1978, 42 days after the submission was received.
What is the product code of K780624?
The FDA product code is GAA – Needle, Aspiration And Injection, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.