The following data is part of a premarket notification filed by Pfm Medical, Inc with the FDA for Asept Peritoneal Drainage System.
| Device ID | K093796 |
| 510k Number | K093796 |
| Device Name: | ASEPT PERITONEAL DRAINAGE SYSTEM |
| Classification | Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling |
| Applicant | PFM MEDICAL, INC 2605 TEMPLE HEIGHTS DRIVE SUITE A Oceanside, CA 92056 |
| Contact | Salvadore Palomares |
| Correspondent | Salvadore Palomares PFM MEDICAL, INC 2605 TEMPLE HEIGHTS DRIVE SUITE A Oceanside, CA 92056 |
| Product Code | PNG |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-11 |
| Decision Date | 2010-02-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10813623019109 | K093796 | 000 |
| 10813623017068 | K093796 | 000 |
| 10813623014227 | K093796 | 000 |
| 10813623011158 | K093796 | 000 |
| 20813623011117 | K093796 | 000 |
| 20813623017041 | K093796 | 000 |
| 04046964317330 | K093796 | 000 |