The following data is part of a premarket notification filed by Ferris Mfg. Corp. with the FDA for Ferris Hydrophilic Dressing (add'l Indications).
Device ID | K900127 |
510k Number | K900127 |
Device Name: | FERRIS HYDROPHILIC DRESSING (ADD'L INDICATIONS) |
Classification | Bandage, Liquid |
Applicant | FERRIS MFG. CORP. 16W300 83RD ST. Burr Ridge, IL 60527 -5848 |
Contact | Demetra E Lalagos |
Correspondent | Demetra E Lalagos FERRIS MFG. CORP. 16W300 83RD ST. Burr Ridge, IL 60527 -5848 |
Product Code | KMF |
CFR Regulation Number | 880.5090 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-01-09 |
Decision Date | 1990-05-18 |