510(k) K896350
K896350 is an FDA 510(k) premarket notification submitted by Acces Intl. Eyewear for the device "TITAN AIR SPECTACLE FRAME". The FDA issued a decision of Substantially Equivalent on December 18, 1989. The device falls under product code HQJ (Implant, Absorbable, (Scleral Buckling Methods)), a Class II device regulated under 21 CFR 886.3300. Acces Intl. Eyewear has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 18, 1989
- Date Received
- November 6, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Implant, Absorbable, (Scleral Buckling Methods)
- Device Class
- Class II
- Regulation Number
- 886.3300
- Review Panel
- OP
- Submission Type