510(k) K033591
K033591 is an FDA 510(k) premarket notification submitted by Clearmedical, Inc. for the device "REPROCESSED TROCARS". The FDA issued a decision of Substantially Equivalent on June 3, 2005. The device falls under product code KBG (Trocar, Sinus), a Class I device regulated under 21 CFR 874.4420. Clearmedical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 3, 2005
- Date Received
- November 13, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Trocar, Sinus
- Device Class
- Class I
- Regulation Number
- 874.4420
- Review Panel
- EN
- Submission Type