510(k) K952538
K952538 is an FDA 510(k) premarket notification submitted by Robert B. Scott Ocularists of Florida, Inc. for the device "ROBERT B. SCOTT PLASTIC ARTIFICAL". The FDA issued a decision of Substantially Equivalent on June 26, 1995. The device falls under product code HQH (Eye, Artificial, Non-Custom), a Class I device regulated under 21 CFR 886.3200. Robert B. Scott Ocularists of Florida, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 26, 1995
- Date Received
- May 31, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Eye, Artificial, Non-Custom
- Device Class
- Class I
- Regulation Number
- 886.3200
- Review Panel
- OP
- Submission Type