510(k) K863983
K863983 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 November 10, 1986. The device falls under product code HJH (Loupe, Binocular, Low Power), a Class I device regulated under 21 CFR 886.5120. Exeter Instruments, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 10, 1986
- Date Received
- October 14, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Loupe, Binocular, Low Power
- Device Class
- Class I
- Regulation Number
- 886.5120
- Review Panel
- OP
- Submission Type