The following data is part of a premarket notification filed by Lifeguard Medical Products, Inc. with the FDA for Levy Articulating Retractor.
Device ID | K920471 |
510k Number | K920471 |
Device Name: | LEVY ARTICULATING RETRACTOR |
Classification | Retractor |
Applicant | LIFEGUARD MEDICAL PRODUCTS, INC. 400 LATHROP AVE. SUITE 200 River Forest, IL 60305 |
Contact | Douglas Hulfish |
Correspondent | Douglas Hulfish LIFEGUARD MEDICAL PRODUCTS, INC. 400 LATHROP AVE. SUITE 200 River Forest, IL 60305 |
Product Code | GAD |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-01-28 |
Decision Date | 1992-06-23 |