510(k) K760697
K760697 is an FDA 510(k) premarket notification submitted by Alcon Laboratories for the device "EVANS ARM AND HAND REST". The FDA issued a decision of Substantially Equivalent on November 2, 1976. The device falls under product code HRK (Table, Instrument, Manual, Ophthalmic), a Class I device regulated under 21 CFR 886.4855. Alcon Laboratories has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 2, 1976
- Date Received
- September 22, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Table, Instrument, Manual, Ophthalmic
- Device Class
- Class I
- Regulation Number
- 886.4855
- Review Panel
- OP
- Submission Type