510(k) K060878
K060878 is an FDA 510(k) premarket notification submitted by Curamedical, BV for the device "GELITA-SPON ABSORBABLE GELATIN SPONGE, USP". The FDA issued a decision of Substantially Equivalent on April 13, 2006. 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
- April 13, 2006
- Date Received
- March 31, 2006
- Clearance Type
- Special
- 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