The following data is part of a premarket notification filed by Blue Sky Medical Group Incorporated with the FDA for Versatile 1 Wound Vacuum System.
| Device ID | K042134 |
| 510k Number | K042134 |
| Device Name: | VERSATILE 1 WOUND VACUUM SYSTEM |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | BLUE SKY MEDICAL GROUP INCORPORATED 1485 POINSETTIA AVE., STE 118 Vista, CA 92083 |
| Contact | Richard Weston |
| Correspondent | Richard Weston BLUE SKY MEDICAL GROUP INCORPORATED 1485 POINSETTIA AVE., STE 118 Vista, CA 92083 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-09 |
| Decision Date | 2004-11-01 |
| Summary: | summary |