Shelhigh No-React Tissue Repair Patch/Uropatch.
FDA 510(k) K991567 · Shelhigh, Inc.
510(k) numberK991567
Submission
- Device name
- Shelhigh No-React Tissue Repair Patch/Uropatch.
- Applicant
- Shelhigh, Inc.
Millburn, NJ, US - Received
- May 5, 1999
- Decision date
- July 14, 1999
- 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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More from Geistlich Pharma AG
| 510(k) | Device | Decision |
|---|---|---|
| K032893 | Shelhigh No-React BiocuffFTL · Traditional | 12/19/2003SE |
| K023940 | Shelhigh BioringKRH · Traditional | 06/04/2003SE |
| K982101 | Shelhigh No-React Dura ShieldGXQ · Traditional | 05/02/2000SE |
| K982810 | Shelhigh No-React VascupatchDXZ · Traditional | 10/28/1998SE |
| K981756 | Shelhigh No-React PneumopledgetsFTL · Traditional | 08/05/1998SE |
| K974914 | Shelhigh No-React Pericardial PatchesDXZ · Traditional | 06/03/1998SE |
| K964467 | Shelhigh Pericardial PatchDXZ · Traditional | 09/23/1997SE |
Questions and answers
When was Shelhigh No-React Tissue Repair Patch/Uropatch. cleared by the FDA?
Shelhigh No-React Tissue Repair Patch/Uropatch. (K991567) received a 510(k) decision of Substantially Equivalent on July 14, 1999, 70 days after the submission was received.
What is the product code of K991567?
The FDA product code is FTM – Mesh, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.3300.