510(k) K831725
K831725 is an FDA 510(k) premarket notification submitted by S. Jackson, Inc. for the device "FOIL IN 3 FORMS-NON-STERILE SHEETS". The FDA issued a decision of Substantially Equivalent on August 16, 1983. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300. S. Jackson, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 16, 1983
- Date Received
- May 31, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- SU
- Submission Type