The following data is part of a premarket notification filed by Orion Life Systems, Inc. with the FDA for Orion Sterile Or Towels.
Device ID | K903117 |
510k Number | K903117 |
Device Name: | ORION STERILE OR TOWELS |
Classification | Drape, Surgical |
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 | KKX |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-07-16 |
Decision Date | 1990-12-31 |