Quarter Globe Caps
FDA 510(k) K831727 · S. Jackson, Inc.
510(k) numberK831727
Submission
- Device name
- Quarter Globe Caps
- Applicant
- S. Jackson, Inc.
Mchenry, IL, US - Received
- May 31, 1983
- Decision date
- August 12, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| K852011 | Nylamid Mesh Pad Full & HalfFTM · Traditional | 06/11/1985SE |
| K831725 | Foil in 3 Forms-Non-Sterile SheetsFTM · Traditional | 08/16/1983SE |
Questions and answers
When was Quarter Globe Caps cleared by the FDA?
Quarter Globe Caps (K831727) received a 510(k) decision of Substantially Equivalent on August 12, 1983, 73 days after the submission was received.
What is the product code of K831727?
The FDA product code is FTM – Mesh, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.3300.