510(k) K810817
K810817 is an FDA 510(k) premarket notification submitted by Exeter Instruments, Inc. for the device "EXETER OPERATING LOUPE". The FDA issued a decision of Substantially Equivalent on April 23, 1981. The device falls under product code HOH (Spectacle, Operating (Loupe), Ophthalmic), a Class I device regulated under 21 CFR 886.4770. Exeter Instruments, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 23, 1981
- Date Received
- March 24, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Spectacle, Operating (Loupe), Ophthalmic
- Device Class
- Class I
- Regulation Number
- 886.4770
- Review Panel
- OP
- Submission Type