The following data is part of a premarket notification filed by Luther Medical Products, Inc. with the FDA for L-cath Expando Cath.
Device ID | K853348 |
510k Number | K853348 |
Device Name: | L-CATH EXPANDO CATH |
Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
Applicant | LUTHER MEDICAL PRODUCTS, INC. 1940 E. OCCIDENTAL ST. Santa Ana, CA 92705 |
Contact | Ronald B Luther |
Correspondent | Ronald B Luther LUTHER MEDICAL PRODUCTS, INC. 1940 E. OCCIDENTAL ST. Santa Ana, CA 92705 |
Product Code | FOZ |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-08-12 |
Decision Date | 1986-01-09 |