510(k) K801466
K801466 is an FDA 510(k) premarket notification submitted by Edward Weck, Inc. for the device "LEIGH MEASURING SCALE #7725". The FDA issued a decision of Substantially Equivalent on July 28, 1980. The device falls under product code HLN (Gauge, Lens, Ophthalmic), a Class I device regulated under 21 CFR 886.1420. Edward Weck, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 28, 1980
- Date Received
- June 24, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gauge, Lens, Ophthalmic
- Device Class
- Class I
- Regulation Number
- 886.1420
- Review Panel
- OP
- Submission Type