The following data is part of a premarket notification filed by Minitube Ab with the FDA for Minitube Dentasleeve Protective Barrier Sleeves.
| Device ID | K211026 |
| 510k Number | K211026 |
| Device Name: | Minitube Dentasleeve Protective Barrier Sleeves |
| Classification | Dental Barriers And Sleeves |
| Applicant | Minitube AB Byvägen 44 Trångsviken, SE 83596 |
| Contact | Bengt Myhrman |
| Correspondent | Vaibhav Arvind Rajal MDI Consultants Inc. 55 Northen Blvd. Suite 200 Great Neck, NY 11021 |
| Product Code | PEM |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-06 |
| Decision Date | 2021-08-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350069420787 | K211026 | 000 |
| 07350069420770 | K211026 | 000 |
| 07350069420763 | K211026 | 000 |