510(k) K971583
K971583 is an FDA 510(k) premarket notification submitted by Porex Technologies Corp. for the device "MEDPOR OCULAR SCREW AND ACCEOSSORIES". The FDA issued a decision of Substantially Equivalent on June 30, 1997. The device falls under product code MQU (Ocular Peg), a Class II device regulated under 21 CFR 886.3320. Porex Technologies Corp. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 30, 1997
- Date Received
- April 30, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ocular Peg
- Device Class
- Class II
- Regulation Number
- 886.3320
- Review Panel
- OP
- Submission Type