The following data is part of a premarket notification filed by Inman Liebelt Corp. with the FDA for Ucez - Sterile Lens Fog Reduction Device.
Device ID | K905590 |
510k Number | K905590 |
Device Name: | UCEZ - STERILE LENS FOG REDUCTION DEVICE |
Classification | Anti Fog Solution And Accessories, Endoscopy |
Applicant | INMAN LIEBELT CORP. P.O.BOX 171077 Arlington, TX 76003 |
Contact | Roger Liebelt |
Correspondent | Roger Liebelt INMAN LIEBELT CORP. P.O.BOX 171077 Arlington, TX 76003 |
Product Code | OCT |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-12-13 |
Decision Date | 1991-05-10 |