The following data is part of a premarket notification filed by Pfm Medical, Inc with the FDA for Asept Pleural Drainage System.
| Device ID | K093307 |
| 510k Number | K093307 |
| Device Name: | ASEPT PLEURAL DRAINAGE SYSTEM |
| Classification | Apparatus, Suction, Patient Care |
| Applicant | PFM MEDICAL, INC 2605 TEMPLE HEIGHTS DRIVE SUITE A Oceanside, CA 92056 |
| Contact | Salvadore Palomares, Rac |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DWM |
| CFR Regulation Number | 870.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-10-22 |
| Decision Date | 2009-11-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10813623017013 | K093307 | 000 |
| 10813623011356 | K093307 | 000 |
| 10813623011165 | K093307 | 000 |
| 04046964317415 | K093307 | 000 |