The following data is part of a premarket notification filed by Orion Life Systems, Inc. with the FDA for Sterile .9% Sodium Chloride Solution.
Device ID | K943834 |
510k Number | K943834 |
Device Name: | STERILE .9% SODIUM CHLORIDE SOLUTION |
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 |