510(k) K021357
K021357 is an FDA 510(k) premarket notification submitted by Porex Surgical, Inc. for the device "MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT". The FDA issued a decision of Substantially Equivalent on Aug 5, 2002. The device falls under product code HPZ (Implant, Eye Sphere), a Class II device regulated under 21 CFR 886.3320. Porex Surgical, Inc. has 18 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 5, 2002
- Date Received
- Apr 29, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Implant, Eye Sphere
- Device Class
- Class II
- Regulation Number
- 886.3320
- Review Panel
- OP
- Submission Type
- 510(k)