The following data is part of a premarket notification filed by Pall Medical with the FDA for Pall Dental Filtration System With Air Water Syringe Housing And Filter Membrane.
| Device ID | K983735 |
| 510k Number | K983735 |
| Device Name: | PALL DENTAL FILTRATION SYSTEM WITH AIR WATER SYRINGE HOUSING AND FILTER MEMBRANE |
| Classification | Unit, Operative Dental |
| Applicant | PALL MEDICAL 2200 NORTHERN BLVD. East Hills, NY 11548 -1209 |
| Contact | Robert A Dickstein |
| Correspondent | Robert A Dickstein PALL MEDICAL 2200 NORTHERN BLVD. East Hills, NY 11548 -1209 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-22 |
| Decision Date | 1999-01-07 |