The following data is part of a premarket notification filed by Isto Technologies, Inc. with the FDA for Inqu Paste Mix.
| Device ID | K111838 |
| 510k Number | K111838 |
| Device Name: | INQU PASTE MIX |
| 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 | 2011-06-29 |
| Decision Date | 2011-09-26 |
| Summary: | summary |