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 |