510(k) K871675

FERRIS TRANSPARENT WOUND DRESSING W/HYDROCOLLOID by Ferris Mfg. Corp. — Product Code FRO

K871675 is an FDA 510(k) premarket notification submitted by Ferris Mfg. Corp. for the device "FERRIS TRANSPARENT WOUND DRESSING W/HYDROCOLLOID". The FDA issued a decision of SN on August 6, 1987. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Ferris Mfg. Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
August 6, 1987
Date Received
April 28, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type