510(k) K011544
K011544 is an FDA 510(k) premarket notification submitted by Seikagaku Corp. for the device "HADGEL, 4 GRAM/SYRINGE". The FDA issued a decision of Substantially Equivalent on Aug 15, 2001. The device falls under product code LYA (Splint, Intranasal Septal), a Class I device regulated under 21 CFR 874.4780.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 15, 2001
- Date Received
- May 18, 2001
- 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
- 510(k) Exempt