Trauma Drainage Set 72T-32TTC
FDA 510(k) K781551 · Sorensen Research
510(k) numberK781551
Submission
- Device name
- Trauma Drainage Set 72T-32TTC
- Applicant
- Sorensen Research
Mchenry, IL, US - Received
- September 12, 1978
- Decision date
- October 26, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CAC – Apparatus, Autotransfusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5830
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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Questions and answers
When was Trauma Drainage Set 72T-32TTC cleared by the FDA?
Trauma Drainage Set 72T-32TTC (K781551) received a 510(k) decision of Substantially Equivalent on October 26, 1978, 44 days after the submission was received.
What is the product code of K781551?
The FDA product code is CAC – Apparatus, Autotransfusion, a Class II (moderate risk) device regulated under 21 CFR 868.5830.