Speedband Superview Super 7, Injection Speedband Superview Super 7, Models 4205 and 4238
FDA 510(k) K020824 · Boston Scientific Corp
510(k) numberK020824
Submission
- Device name
- Speedband Superview Super 7, Injection Speedband Superview Super 7, Models 4205 and 4238
- Applicant
- Boston Scientific Corp
Natick,, MA, US - Received
- March 14, 2002
- Decision date
- April 12, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FHN – Ligator, Hemorrhoidal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4400
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was Speedband Superview Super 7, Injection Speedband Superview Super 7, Models 4205 and 4238 cleared by the FDA?
Speedband Superview Super 7, Injection Speedband Superview Super 7, Models 4205 and 4238 (K020824) received a 510(k) decision of Substantially Equivalent on April 12, 2002, 29 days after the submission was received.
What is the product code of K020824?
The FDA product code is FHN – Ligator, Hemorrhoidal, a Class II (moderate risk) device regulated under 21 CFR 876.4400.