510(k) K911734
K911734 is an FDA 510(k) premarket notification submitted by Northland Cataract & Eye Care Clinic for the device "TEARTEC RAPID LACRIMAL ASSESMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on November 7, 1991. The device falls under product code KYD (Strip, Schirmer), a Class I device regulated under 21 CFR 886.1800.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 7, 1991
- Date Received
- April 17, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Strip, Schirmer
- Device Class
- Class I
- Regulation Number
- 886.1800
- Review Panel
- OP
- Submission Type