The following data is part of a premarket notification filed by Level 1 Technologies, Inc. with the FDA for Pressure Irrigating System.
| Device ID | K936223 |
| 510k Number | K936223 |
| Device Name: | PRESSURE IRRIGATING SYSTEM |
| Classification | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
| Applicant | LEVEL 1 TECHNOLOGIES, INC. 160 WEYMOUTH ST. Rockland, MA 02370 |
| Contact | Allan J Pulsifer |
| Correspondent | Allan J Pulsifer LEVEL 1 TECHNOLOGIES, INC. 160 WEYMOUTH ST. Rockland, MA 02370 |
| Product Code | GCY |
| CFR Regulation Number | 878.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-29 |
| Decision Date | 1994-05-12 |