The following data is part of a premarket notification filed by Orion Life Systems, Inc. with the FDA for Suction Catheter, Sterile.
Device ID | K902814 |
510k Number | K902814 |
Device Name: | SUCTION CATHETER, STERILE |
Classification | Catheters, Suction, Tracheobronchial |
Applicant | ORION LIFE SYSTEMS, INC. 124 MESSNER DR. Wheeling, IL 60090 |
Contact | John L Laemmar |
Correspondent | John L Laemmar ORION LIFE SYSTEMS, INC. 124 MESSNER DR. Wheeling, IL 60090 |
Product Code | BSY |
CFR Regulation Number | 868.6810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-06-28 |
Decision Date | 1990-08-17 |