The following data is part of a premarket notification filed by Ferris Mfg. Corp. with the FDA for I.v. Starter Tray W/dynaderm Transparent Adhesive.
Device ID | K852375 |
510k Number | K852375 |
Device Name: | I.V. STARTER TRAY W/DYNADERM TRANSPARENT ADHESIVE |
Classification | I.v. Start Kit |
Applicant | FERRIS MFG. CORP. 16W300 83RD ST. Burr Ridge, IL 60527 -5848 |
Contact | Carl Hays |
Correspondent | Carl Hays FERRIS MFG. CORP. 16W300 83RD ST. Burr Ridge, IL 60527 -5848 |
Product Code | LRS |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent - With Drug (SESD) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-06-04 |
Decision Date | 1985-07-11 |