Coagulation Control, Level III
FDA 510(k) K902363 · Sigma Chemical Co.
510(k) numberK902363
Submission
- Device name
- Coagulation Control, Level III
- Applicant
- Sigma Chemical Co.
St. Louis, MO, US - Received
- May 29, 1990
- Decision date
- July 26, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GGN – Plasma, Coagulation Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5425
- Specialty
- Hematology
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Questions and answers
When was Coagulation Control, Level III cleared by the FDA?
Coagulation Control, Level III (K902363) received a 510(k) decision of Substantially Equivalent on July 26, 1990, 58 days after the submission was received.
What is the product code of K902363?
The FDA product code is GGN – Plasma, Coagulation Control, a Class II (moderate risk) device regulated under 21 CFR 864.5425.