510(k) K902187
K902187 is an FDA 510(k) premarket notification submitted by Nurion Industries for the device "POLARON". The FDA issued a decision of Substantially Equivalent on August 8, 1990. The device falls under product code HPG (Aid, Vision, Electronic, Battery-Powered), a Class I device regulated under 21 CFR 886.5900. Nurion Industries has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 8, 1990
- Date Received
- May 14, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Aid, Vision, Electronic, Battery-Powered
- Device Class
- Class I
- Regulation Number
- 886.5900
- Review Panel
- OP
- Submission Type