510(k) K930628
K930628 is an FDA 510(k) premarket notification submitted by Bova Intl. for the device "KLAAS IOL LENSFOLDER". The FDA issued a decision of Substantially Equivalent on February 7, 1995. The device falls under product code KYB (Lens, Guide, Intraocular), a Class I device regulated under 21 CFR 886.4300. Bova Intl. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 7, 1995
- Date Received
- February 8, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lens, Guide, Intraocular
- Device Class
- Class I
- Regulation Number
- 886.4300
- Review Panel
- OP
- Submission Type