510(k) K801231
K801231 is an FDA 510(k) premarket notification submitted by Coburn Optical Ind., Inc. for the device "EYE-VAC". The FDA issued a decision of Substantially Equivalent on July 21, 1980. The device falls under product code HKP (Instrument, Vitreous Aspiration And Cutting, Battery-Powered), a Class II device regulated under 21 CFR 886.4150. Coburn Optical Ind., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 21, 1980
- Date Received
- May 27, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Vitreous Aspiration And Cutting, Battery-Powered
- Device Class
- Class II
- Regulation Number
- 886.4150
- Review Panel
- OP
- Submission Type