510(k) K882762
K882762 is an FDA 510(k) premarket notification submitted by Chiron Ophthalmics for the device "COLLAGEN SHIELD". The FDA issued a decision of Substantially Equivalent on September 12, 1988. The device falls under product code MOE (Collagen Corneal Shield), a Class I device regulated under 21 CFR 886.4750. Chiron Ophthalmics has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 12, 1988
- Date Received
- July 6, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Collagen Corneal Shield
- Device Class
- Class I
- Regulation Number
- 886.4750
- Review Panel
- OP
- Submission Type