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 |