510(k) K911374
K911374 is an FDA 510(k) premarket notification submitted by National Reading Service for the device "PLASTIC OVERLAYS". The FDA issued a decision of Substantially Equivalent on July 26, 1991. The device falls under product code HKW (Prism, Bar, Ophthalmic), a Class I device regulated under 21 CFR 886.1650.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 26, 1991
- Date Received
- March 28, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prism, Bar, Ophthalmic
- Device Class
- Class I
- Regulation Number
- 886.1650
- Review Panel
- OP
- Submission Type