510(k) K181696
K181696 is an FDA 510(k) premarket notification submitted by Gyrus Acmi, Inc. for the device "ChitoZolve". The FDA issued a decision of Substantially Equivalent on November 30, 2018. The device falls under product code LYA (Splint, Intranasal Septal), a Class I device regulated under 21 CFR 874.4780. Gyrus Acmi, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 30, 2018
- Date Received
- June 27, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Splint, Intranasal Septal
- Device Class
- Class I
- Regulation Number
- 874.4780
- Review Panel
- EN
- Submission Type