The following data is part of a premarket notification filed by Pfm Produkte Fur Die Medizin Ag with the FDA for Redon Set.
| Device ID | K001716 |
| 510k Number | K001716 |
| Device Name: | REDON SET |
| Classification | Apparatus, Suction, Ward Use, Portable, Ac-powered |
| Applicant | PFM PRODUKTE FUR DIE MEDIZIN AG 154 VIA LAMPARA Rancho Santa Margarita, CA 92688 |
| Contact | Salvadore F Palomares |
| Correspondent | Salvadore F Palomares PFM PRODUKTE FUR DIE MEDIZIN AG 154 VIA LAMPARA Rancho Santa Margarita, CA 92688 |
| Product Code | JCX |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-05 |
| Decision Date | 2000-07-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10813623015378 | K001716 | 000 |
| 10813623011257 | K001716 | 000 |
| 10813623011240 | K001716 | 000 |
| 10813623011219 | K001716 | 000 |
| 10813623011202 | K001716 | 000 |
| 10813623011196 | K001716 | 000 |
| 10813623011189 | K001716 | 000 |
| 04046964317149 | K001716 | 000 |
| 04046964317101 | K001716 | 000 |