510(k) K903823

SPEEDWRAP, DYNAWRAP, DYNAPLAST TAPE by Smith And Nephew Donjoy, Inc. — Product Code KGX

K903823 is an FDA 510(k) premarket notification submitted by Smith And Nephew Donjoy, Inc. for the device "SPEEDWRAP, DYNAWRAP, DYNAPLAST TAPE". The FDA issued a decision of Substantially Equivalent on Jan 16, 1991. The device falls under product code KGX (Tape And Bandage, Adhesive), a Class I device regulated under 21 CFR 880.5240. Smith And Nephew Donjoy, Inc. has 14 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Jan 16, 1991
Date Received
Aug 20, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Tape And Bandage, Adhesive
Device Class
Class I
Regulation Number
880.5240
Review Panel
SU
Submission Type
510(k) Exempt

Source: FDA 510(k) database entry for K903823. Report a data issue: hello@regdatalab.com.