The following data is part of a premarket notification filed by Porex Technologies Corp. with the FDA for Medpor Ocular Screw And Acceossories.
Device ID | K971583 |
510k Number | K971583 |
Device Name: | MEDPOR OCULAR SCREW AND ACCEOSSORIES |
Classification | Ocular Peg |
Applicant | POREX TECHNOLOGIES CORP. 500 BOHANNON RD. Fairburn, GA 30213 |
Contact | Howard Mercer |
Correspondent | Howard Mercer POREX TECHNOLOGIES CORP. 500 BOHANNON RD. Fairburn, GA 30213 |
Product Code | MQU |
CFR Regulation Number | 886.3320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-04-30 |
Decision Date | 1997-06-30 |
Summary: | summary |