The following data is part of a premarket notification filed by Porex Surgical, Inc. with the FDA for Medpor Quad Motility Implant.
Device ID | K010902 |
510k Number | K010902 |
Device Name: | MEDPOR QUAD MOTILITY IMPLANT |
Classification | Implant, Eye Sphere |
Applicant | POREX SURGICAL, INC. 15 DART RD. Newnan, GA 30265 |
Contact | Howard Mercer |
Correspondent | Howard Mercer 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 | 2001-03-26 |
Decision Date | 2001-06-19 |