The following data is part of a premarket notification filed by Bennett Jacoby, Dds, Ms, Inc. with the FDA for Contour P-insert 90, Contour P-insert 45, Contour P-insert Tri Tip, Contour P-insert Wc Tip, Contour P-insert Quad Tip.
| Device ID | K192033 |
| 510k Number | K192033 |
| Device Name: | Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip |
| Classification | Drill, Bone, Powered |
| Applicant | Bennett Jacoby, DDS, MS, Inc. 77-6425 Kuakini Hwy, C2-84 Kailua Kona, HI 96740 |
| Contact | Bennett Jacoby |
| Correspondent | Marc C. Sanchez Contract In-House Counsel & Consultants, LLC (d/b/a FDA Atty 53516 Bickett Chapel Hill, NC 27517 |
| Product Code | DZI |
| CFR Regulation Number | 872.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-30 |
| Decision Date | 2020-06-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D966S90AV10 | K192033 | 000 |
| D966S45AV10 | K192033 | 000 |
| D966TTA0 | K192033 | 000 |
| D966T18V240 | K192033 | 000 |
| D966T16V300 | K192033 | 000 |
| D966T15V500 | K192033 | 000 |
| D966T15V330 | K192033 | 000 |