The following data is part of a premarket notification filed by Ferris Mfg. Corp. with the FDA for Ferris Dynaderm Plus.
Device ID | K865089 |
510k Number | K865089 |
Device Name: | FERRIS DYNADERM PLUS |
Classification | Dressing, Wound, Drug |
Applicant | FERRIS MFG. CORP. 16W300 83RD ST. Burr Ridge, IL 60527 -5848 |
Contact | Robert W Sessions |
Correspondent | Robert W Sessions FERRIS MFG. CORP. 16W300 83RD ST. Burr Ridge, IL 60527 -5848 |
Product Code | FRO |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-12-30 |
Decision Date | 1987-02-04 |