The following data is part of a premarket notification filed by Pall Medical with the FDA for Pall Surgiclear Laparoscopic Smoke Filtration System, Model Clsf1.
| Device ID | K992361 |
| 510k Number | K992361 |
| Device Name: | PALL SURGICLEAR LAPAROSCOPIC SMOKE FILTRATION SYSTEM, MODEL CLSF1 |
| Classification | Apparatus, Exhaust, Surgical |
| Applicant | PALL MEDICAL 2200 NORTHERN BLVD. East Hills, NY 11548 -1209 |
| Contact | Leonard S Berman |
| Correspondent | Leonard S Berman PALL MEDICAL 2200 NORTHERN BLVD. East Hills, NY 11548 -1209 |
| Product Code | FYD |
| CFR Regulation Number | 878.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-15 |
| Decision Date | 1999-08-20 |