Scanlan Suture Boots
FDA 510(k) K810480 · Scanlan Intl., Inc.
510(k) numberK810480
Submission
- Device name
- Scanlan Suture Boots
- Applicant
- Scanlan Intl., Inc.
Mchenry, IL, US - Received
- February 23, 1981
- Decision date
- March 13, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KOC – Accessories, Blood Circuit, Hemodialysis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
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Questions and answers
When was Scanlan Suture Boots cleared by the FDA?
Scanlan Suture Boots (K810480) received a 510(k) decision of Substantially Equivalent on March 13, 1981, 18 days after the submission was received.
What is the product code of K810480?
The FDA product code is KOC – Accessories, Blood Circuit, Hemodialysis, a Class II (moderate risk) device regulated under 21 CFR 876.5820.