510(k) K900279
K900279 is an FDA 510(k) premarket notification submitted by Oculinum, Inc. for the device "OCULINUM INJECTION AMPLIFIER". The FDA issued a decision of Substantially Equivalent on February 9, 1990. The device falls under product code HLW (Preamplifier, Battery-Powered, Ophthalmic), a Class II device regulated under 21 CFR 886.1640. Oculinum, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 9, 1990
- Date Received
- January 8, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Preamplifier, Battery-Powered, Ophthalmic
- Device Class
- Class II
- Regulation Number
- 886.1640
- Review Panel
- OP
- Submission Type