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 |