The following data is part of a premarket notification filed by Isto Technologies, Inc. with the FDA for Inqu.
Device ID | K071428 |
510k Number | K071428 |
Device Name: | INQU |
Classification | Filler, Bone Void, Calcium Compound |
Applicant | ISTO TECHNOLOGIES, INC. 5600 WISCONSIN AVE. #509 Chevy Chase, MD 20815 |
Contact | Patsy J Trisler |
Correspondent | Patsy J Trisler ISTO TECHNOLOGIES, INC. 5600 WISCONSIN AVE. #509 Chevy Chase, MD 20815 |
Product Code | MQV |
CFR Regulation Number | 888.3045 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-05-23 |
Decision Date | 2007-09-17 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
M896IQSPMX1250 | K071428 | 000 |
M896IQSPGR1300 | K071428 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
INQU 78664434 3336291 Live/Registered |
ISTO TECHNOLOGIES II, LLC 2005-07-06 |