The following data is part of a premarket notification filed by Blue Sky Medical Group Incorporated with the FDA for Bluesky Vista Wound Vacuum System, Model 100.0500.
| Device ID | K061367 |
| 510k Number | K061367 |
| Device Name: | BLUESKY VISTA WOUND VACUUM SYSTEM, MODEL 100.0500 |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | BLUE SKY MEDICAL GROUP INCORPORATED 5924 BALFOUR CT. SUITE 102 Carlsbad, CA 92008 |
| Contact | Jasper Benke |
| Correspondent | Jasper Benke BLUE SKY MEDICAL GROUP INCORPORATED 5924 BALFOUR CT. SUITE 102 Carlsbad, CA 92008 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-16 |
| Decision Date | 2006-08-10 |