The following data is part of a premarket notification filed by Black & Black Surgical, Inc. with the FDA for Vitruvian Ultimate Aspirator.
| Device ID | K161722 |
| 510k Number | K161722 |
| Device Name: | VITRUVIAN ULTIMATE ASPIRATOR |
| Classification | System, Suction, Lipoplasty |
| Applicant | BLACK & BLACK SURGICAL, INC. 5238 ROYAL WOODS PKWY, SUITE 170 Tucker, GA 30084 |
| Contact | Cynthia Rees |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | MUU |
| CFR Regulation Number | 878.5040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2016-06-22 |
| Decision Date | 2016-07-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B089B890250 | K161722 | 000 |