510(k) K781892
K781892 is an FDA 510(k) premarket notification submitted by Keeler Optical Products , Ltd. for the device "LOCATOR, FOREIGN BODY". The FDA issued a decision of Substantially Equivalent on December 4, 1978. The device falls under product code HPM (Locator, Metal, Electronic), a Class II device regulated under 21 CFR 886.4400. Keeler Optical Products , Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 4, 1978
- Date Received
- November 8, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Locator, Metal, Electronic
- Device Class
- Class II
- Regulation Number
- 886.4400
- Review Panel
- OP
- Submission Type