The following data is part of a premarket notification filed by Porex Surgical, Inc. with the FDA for Medpor Attractor Implant.
Device ID | K071335 |
510k Number | K071335 |
Device Name: | MEDPOR ATTRACTOR IMPLANT |
Classification | Implant, Eye Sphere |
Applicant | POREX SURGICAL, INC. 15 DART RD. Newnan, GA 30265 |
Contact | Jerri L Davis |
Correspondent | Jerri L Davis POREX SURGICAL, INC. 15 DART RD. Newnan, GA 30265 |
Product Code | HPZ |
CFR Regulation Number | 886.3320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-05-11 |
Decision Date | 2007-08-08 |
Summary: | summary |