The following data is part of a premarket notification filed by Laser Engineering, Inc. with the FDA for Bipure 1000.
| Device ID | K912347 |
| 510k Number | K912347 |
| Device Name: | BIPURE 1000 |
| Classification | Apparatus, Exhaust, Surgical |
| Applicant | LASER ENGINEERING, INC. 113 CEDAR ST. Milford, MA 01757 |
| Contact | Robert I.rudko |
| Correspondent | Robert I.rudko LASER ENGINEERING, INC. 113 CEDAR ST. Milford, MA 01757 |
| Product Code | FYD |
| CFR Regulation Number | 878.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-28 |
| Decision Date | 1991-09-23 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BIPURE 1000 74310029 1772892 Dead/Cancelled |
Laser Engineering, Inc. 1992-09-02 |