510(k) K970327
K970327 is an FDA 510(k) premarket notification submitted by Southwest Artificial Eyes, Inc. for the device "SCLERAL SHELL". The FDA issued a decision of Substantially Equivalent on July 7, 1997. The device falls under product code HQT (Shell, Scleral), a Class II device regulated under 21 CFR 886.3800. Southwest Artificial Eyes, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 7, 1997
- Date Received
- January 28, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Shell, Scleral
- Device Class
- Class II
- Regulation Number
- 886.3800
- Review Panel
- OP
- Submission Type