The following data is part of a premarket notification filed by Pall International Sarl with the FDA for Pall Qpoint Water Filter Capsule (shower), Pall Qpoint Water Filter Capsule (faucet).
| Device ID | K163609 |
| 510k Number | K163609 |
| Device Name: | Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Faucet) |
| Classification | System, Water Purification, General Medical Use |
| Applicant | PALL INTERNATIONAL SARL AVENUE DE TIVOLI 3 Fribourg, CH Ch-1700 |
| Contact | Karen Peterson-doyle |
| Correspondent | Randy Prebula Hogan Lovells U.S. LLP 555 Thirteenth Street NW Washington, DC 20004 |
| Product Code | NHV |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-22 |
| Decision Date | 2017-06-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05034480315670 | K163609 | 000 |
| 35034480314797 | K163609 | 000 |
| 35034480315503 | K163609 | 000 |
| 35034480315510 | K163609 | 000 |
| 35034480315527 | K163609 | 000 |
| 35034480315534 | K163609 | 000 |
| 05034480315649 | K163609 | 000 |
| 05034480315656 | K163609 | 000 |
| 05034480315663 | K163609 | 000 |
| 05034480315601 | K163609 | 000 |