The following data is part of a premarket notification filed by Bone Solutions, Inc. with the FDA for Bone Solutions Mixing And Delivery System.
Device ID | K161568 |
510k Number | K161568 |
Device Name: | Bone Solutions Mixing And Delivery System |
Classification | Syringe, Piston |
Applicant | BONE SOLUTIONS, INC. 5712 COLLEYVILLE BLVD, SUITE 210 Colleyville, TX 76034 |
Contact | Drew Diaz |
Correspondent | Drew Diaz BONE SOLUTIONS, INC. 5712 COLLEYVILLE BLVD, SUITE 210 Colleyville, TX 76034 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-06-07 |
Decision Date | 2016-09-16 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00842528128787 | K161568 | 000 |
00842528128770 | K161568 | 000 |
00842528128756 | K161568 | 000 |