The following data is part of a premarket notification filed by Dimensional Bioceramics Llc with the FDA for Dimensional Bioceramics Calcium Sulfate Device (db-csd).
Device ID | K171161 |
510k Number | K171161 |
Device Name: | Dimensional Bioceramics Calcium Sulfate Device (DB-CSD) |
Classification | Filler, Bone Void, Calcium Compound |
Applicant | Dimensional Bioceramics LLC 163 McKenzie Creek Road Scotts Valley, CA 95066 |
Contact | David Delaney |
Correspondent | Patsy J. Trisler Trisler Consulting 5600 Wisconsin Avenue #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 | 2017-04-20 |
Decision Date | 2017-09-25 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00850018568210 | K171161 | 000 |
00850018568203 | K171161 | 000 |
00850018568197 | K171161 | 000 |