The following data is part of a premarket notification filed by Advanced Back Technologies with the FDA for Extentrac Elite.
Device ID | K031996 |
510k Number | K031996 |
Device Name: | EXTENTRAC ELITE |
Classification | Equipment, Traction, Powered |
Applicant | ADVANCED BACK TECHNOLOGIES 227 JACKSON AVE. Syosset, NY 11791 |
Contact | David F Cuccia |
Correspondent | David F Cuccia ADVANCED BACK TECHNOLOGIES 227 JACKSON AVE. Syosset, NY 11791 |
Product Code | ITH |
CFR Regulation Number | 890.5900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-06-27 |
Decision Date | 2004-07-23 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B727M100 | K031996 | 000 |