510(k) K051911
K051911 is an FDA 510(k) premarket notification submitted by Curamedical, BV for the device "GELITA-SPON". The FDA issued a decision of Substantially Equivalent on December 6, 2005. The device falls under product code KHJ (Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)), a Class II device regulated under 21 CFR 874.3620. Curamedical, BV has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 6, 2005
- Date Received
- July 14, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
- Device Class
- Class II
- Regulation Number
- 874.3620
- Review Panel
- EN
- Submission Type