The following data is part of a premarket notification filed by Pall International, Sarl with the FDA for Pall-aquasafe Water Filter.
| Device ID | K153434 |
| 510k Number | K153434 |
| Device Name: | Pall-Aquasafe Water Filter |
| Classification | System, Water Purification, General Medical Use |
| Applicant | PALL INTERNATIONAL, SARL AVE DE TIVOLI3 Fribourg, CH 1700 |
| Contact | Karen D Peterson-doyle |
| Correspondent | Karen D Peterson-doyle PALL INTERNATIONAL, SARL AVE DE TIVOLI 3 Fribourg, CH 1700 |
| Product Code | NHV |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-27 |
| Decision Date | 2016-06-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 35034480314803 | K153434 | 000 |
| 35034480313752 | K153434 | 000 |
| 35034480313745 | K153434 | 000 |
| 35034480313691 | K153434 | 000 |
| 35034480313554 | K153434 | 000 |