510(k) K832181
K832181 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "SNO STRIPS STERILE TEARFLOW TEST STRIP". The FDA issued a decision of Substantially Equivalent on August 12, 1983. The device falls under product code KYD (Strip, Schirmer), a Class I device regulated under 21 CFR 886.1800. Smith & Nephew, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 12, 1983
- Date Received
- July 6, 1983
- 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