The following data is part of a premarket notification filed by Atrion Medical Products, Inc. with the FDA for Atrion Medical Ql Inflation Device.
Device ID | K032840 |
510k Number | K032840 |
Device Name: | ATRION MEDICAL QL INFLATION DEVICE |
Classification | Dilator, Urethral |
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 | KOE |
CFR Regulation Number | 876.5520 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-09-11 |
Decision Date | 2004-03-03 |
Summary: | summary |