The following data is part of a premarket notification filed by Investigacion Farmaceutica S.a. De C.v. with the FDA for Ifa Sensibac Nitrofurantoin.
| Device ID | K892715 |
| 510k Number | K892715 |
| Device Name: | IFA SENSIBAC NITROFURANTOIN |
| Classification | Susceptibility Test Discs, Antimicrobial |
| Applicant | INVESTIGACION FARMACEUTICA S.A. DE C.V. CALLE 13-E NO. 5 CIVAC JIUTEPEC, MORELOS Mexico, MX |
| Contact | Smithers Hoggs |
| Correspondent | Smithers Hoggs INVESTIGACION FARMACEUTICA S.A. DE C.V. CALLE 13-E NO. 5 CIVAC JIUTEPEC, MORELOS Mexico, MX |
| Product Code | JTN |
| CFR Regulation Number | 866.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-14 |
| Decision Date | 1989-08-03 |