510(k) K122561
K122561 is an FDA 510(k) premarket notification submitted by Ceremed , Inc. for the device "ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN". The FDA issued a decision of Substantially Equivalent on November 27, 2012. 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. Ceremed , Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 27, 2012
- Date Received
- August 22, 2012
- 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