The following data is part of a premarket notification filed by Franklin Medical Usa, Inc. with the FDA for Simplastic Supra Pubic Catheter.
| Device ID | K852200 |
| 510k Number | K852200 |
| Device Name: | SIMPLASTIC SUPRA PUBIC CATHETER |
| Classification | Catheter, Suprapubic (and Accessories) |
| Applicant | FRANKLIN MEDICAL USA, INC. 340 INTERSTATE NORTH SUITE 140 Atlanta, GA 30339 |
| Contact | Hung |
| Correspondent | Hung FRANKLIN MEDICAL USA, INC. 340 INTERSTATE NORTH SUITE 140 Atlanta, GA 30339 |
| Product Code | KOB |
| CFR Regulation Number | 876.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-21 |
| Decision Date | 1985-08-07 |