Tutopatch
FDA 510(k) K991296 · Tutogen Medical U.S., Inc.
510(k) numberK991296
Submission
- Device name
- Tutopatch
- Applicant
- Tutogen Medical U.S., Inc.
Alachua, FL, US - Received
- April 15, 1999
- Decision date
- October 6, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FTM – Mesh, Surgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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Questions and answers
When was Tutopatch cleared by the FDA?
Tutopatch (K991296) received a 510(k) decision of Substantially Equivalent on October 6, 2000, 540 days after the submission was received.
What is the product code of K991296?
The FDA product code is FTM – Mesh, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.3300.