The following data is part of a premarket notification filed by Mastel Precision Surgical Instruments, Inc. with the FDA for Mastel Laser Clean Room, Model Ebs-100.
| Device ID | K043494 |
| 510k Number | K043494 |
| Device Name: | MASTEL LASER CLEAN ROOM, MODEL EBS-100 |
| Classification | Apparatus, Exhaust, Surgical |
| Applicant | MASTEL PRECISION SURGICAL INSTRUMENTS, INC. 2843 SAMCO RD., SUITE A Rapid City, SD 57702 -9366 |
| Contact | Merle Goeringer |
| Correspondent | Merle Goeringer MASTEL PRECISION SURGICAL INSTRUMENTS, INC. 2843 SAMCO RD., SUITE A Rapid City, SD 57702 -9366 |
| Product Code | FYD |
| CFR Regulation Number | 878.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-17 |
| Decision Date | 2005-10-04 |
| Summary: | summary |