510(k) K000637
K000637 is an FDA 510(k) premarket notification submitted by Alcon Laboratories, Inc. for the device "CUSTOMCORNEA MEASUREMENT DEVICE (CCMD)". The FDA issued a decision of SESU on May 19, 2000. The device falls under product code NCF (Aberrometer, Ophthalmic), a Class I device regulated under 21 CFR 886.1760. Alcon Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESU ()
- Decision Date
- May 19, 2000
- Date Received
- February 25, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Aberrometer, Ophthalmic
- Device Class
- Class I
- Regulation Number
- 886.1760
- Review Panel
- OP
- Submission Type