The following data is part of a premarket notification filed by Orion Life Systems, Inc. with the FDA for Pre-filled 30cc Inflation Syringe W/sterile Water.
| Device ID | K943831 |
| 510k Number | K943831 |
| Device Name: | PRE-FILLED 30CC INFLATION SYRINGE W/STERILE WATER |
| Classification | Catheter And Tip, Suction |
| Applicant | ORION LIFE SYSTEMS, INC. P.O. BOX 2308 Palm Harbor, FL 34682 -2308 |
| Contact | Patrick J Lamb |
| Correspondent | Patrick J Lamb ORION LIFE SYSTEMS, INC. P.O. BOX 2308 Palm Harbor, FL 34682 -2308 |
| Product Code | JOL |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-05 |
| Decision Date | 1994-11-21 |