510(k) K844657
K844657 is an FDA 510(k) premarket notification submitted by Pro Design Intl. AS for the device "SPECTABLE FRAME MAGNIFYING BRILLETTE". The FDA issued a decision of Substantially Equivalent on December 11, 1984. The device falls under product code HOJ (Screen, Tangent, Target), a Class I device regulated under 21 CFR 886.1810. Pro Design Intl. AS has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 11, 1984
- Date Received
- November 29, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Screen, Tangent, Target
- Device Class
- Class I
- Regulation Number
- 886.1810
- Review Panel
- OP
- Submission Type