The following data is part of a premarket notification filed by Ebi, L.p. with the FDA for Modification To Ebi Xfix Vision Fixation System.
Device ID | K014194 |
510k Number | K014194 |
Device Name: | MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM |
Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
Applicant | EBI, L.P. 399 JEFFERSON ROAD Parsippany, NJ 07054 |
Contact | Patricia M Flood |
Correspondent | Patricia M Flood EBI, L.P. 399 JEFFERSON ROAD Parsippany, NJ 07054 |
Product Code | KTT |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-12-21 |
Decision Date | 2002-01-17 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00880304509665 | K014194 | 000 |
00880304505070 | K014194 | 000 |
00880304492950 | K014194 | 000 |
00880304491229 | K014194 | 000 |
00887868098390 | K014194 | 000 |