The following data is part of a premarket notification filed by Integra Radionics, Inc. with the FDA for Cusa Nxt Extended Length Tip.
Device ID | K102258 |
510k Number | K102258 |
Device Name: | CUSA NXT EXTENDED LENGTH TIP |
Classification | Instrument, Ultrasonic Surgical |
Applicant | INTEGRA RADIONICS, INC. 22 TERRY AVENUE Burlington, MA 01803 |
Contact | Kevin J O'connell |
Correspondent | Kevin J O'connell INTEGRA RADIONICS, INC. 22 TERRY AVENUE Burlington, MA 01803 |
Product Code | LFL |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-08-10 |
Decision Date | 2011-06-10 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10381780039518 | K102258 | 000 |