510(k) K955366
K955366 is an FDA 510(k) premarket notification submitted by Rand Scientific Corp. for the device "TRANS-AIRE RIGID GAS PERMABLE CONTACT LENS". The FDA issued a decision of Substantially Equivalent on March 28, 1996. The device falls under product code HQD (Lens, Contact (Other Material) - Daily), a Class II device regulated under 21 CFR 886.5916. Rand Scientific Corp. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 28, 1996
- Date Received
- November 22, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lens, Contact (Other Material) - Daily
- Device Class
- Class II
- Regulation Number
- 886.5916
- Review Panel
- OP
- Submission Type