510(k) K883489
K883489 is an FDA 510(k) premarket notification submitted by Coopervision-Cilco for the device "KRATZ NOVA SERT(TM)". The FDA issued a decision of Substantially Equivalent on Oct 25, 1988. The device falls under product code KYB (Lens, Guide, Intraocular), a Class I device regulated under 21 CFR 886.4300. Coopervision-Cilco has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 25, 1988
- Date Received
- Aug 16, 1988
- 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
- 510(k) Exempt