The following data is part of a premarket notification filed by Summit Medical Products, Inc with the FDA for Direct Antibiotic Infusion Kit.
| Device ID | K113043 |
| 510k Number | K113043 |
| Device Name: | DIRECT ANTIBIOTIC INFUSION KIT |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | SUMMIT MEDICAL PRODUCTS, INC 2480 S Main St Ste 212 Salt Lake Cty, UT 84115 |
| Contact | Marko V Amen |
| Correspondent | Marko V Amen SUMMIT MEDICAL PRODUCTS, INC 2480 S Main St Ste 212 Salt Lake Cty, UT 84115 |
| Product Code | LJS |
| Subsequent Product Code | FRO |
| Subsequent Product Code | GAT |
| Subsequent Product Code | JCY |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2011-10-13 |
| Decision Date | 2011-12-20 |
| Summary: | summary |