The following data is part of a premarket notification filed by Atrion Medical Products, Inc. with the FDA for Atrion Medical Products Lacrimal Intubation Set.
Device ID | K973633 |
510k Number | K973633 |
Device Name: | ATRION MEDICAL PRODUCTS LACRIMAL INTUBATION SET |
Classification | Lacrimal Stents And Intubation Sets |
Applicant | ATRION MEDICAL PRODUCTS, INC. 1426 CURT FRANCIS RD. Arab, AL 35016 |
Contact | Dan Clark |
Correspondent | Dan Clark ATRION MEDICAL PRODUCTS, INC. 1426 CURT FRANCIS RD. Arab, AL 35016 |
Product Code | OKS |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-07-17 |
Decision Date | 1998-01-16 |
Summary: | summary |