The following data is part of a premarket notification filed by Porex Technologies Corp. Of Georgia with the FDA for Medpor Ocular Peg System And Accessories.
Device ID | K960859 |
510k Number | K960859 |
Device Name: | MEDPOR OCULAR PEG SYSTEM AND ACCESSORIES |
Classification | Implant, Eye Sphere |
Applicant | POREX TECHNOLOGIES CORP. OF GEORGIA 500 BOHANNON RD. Fairburn, GA 30213 |
Contact | Howard Mercer, Ph.d. |
Correspondent | Howard Mercer, Ph.d. POREX TECHNOLOGIES CORP. OF GEORGIA 500 BOHANNON RD. Fairburn, GA 30213 |
Product Code | HPZ |
CFR Regulation Number | 886.3320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-03-01 |
Decision Date | 1996-05-29 |
Summary: | summary |