The following data is part of a premarket notification filed by Cgbio Co., Ltd with the FDA for Kulavac.
| Device ID | K122490 |
| 510k Number | K122490 |
| Device Name: | KULAVAC |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | CGBIO CO., LTD 163-3 SAMSUNG-DONG KANGNAM-GU Seoul, KR 135-715 |
| Contact | Jungeun Im |
| Correspondent | Jungeun Im CGBIO CO., LTD 163-3 SAMSUNG-DONG KANGNAM-GU Seoul, KR 135-715 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-15 |
| Decision Date | 2013-11-13 |
| Summary: | summary |