510(k) K874161

MODIFIED USE OF TRIANGLE BANDAGE STERILE by K. W. Griffen Co. — Product Code NAD

K874161 is an FDA 510(k) premarket notification submitted by K. W. Griffen Co. for the device "MODIFIED USE OF TRIANGLE BANDAGE STERILE". The FDA issued a decision of Substantially Equivalent on December 4, 1987. The device falls under product code NAD (Dressing, Wound, Occlusive), a Class I device regulated under 21 CFR 878.4020. K. W. Griffen Co. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 1987
Date Received
October 13, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Occlusive
Device Class
Class I
Regulation Number
878.4020
Review Panel
SU
Submission Type