510(k) K860804

MEDICAL ADHESIVE TAPE by W.R. Grace & Co.-Conn. — Product Code KGX

K860804 is an FDA 510(k) premarket notification submitted by W.R. Grace & Co.-Conn. for the device "MEDICAL ADHESIVE TAPE". The FDA issued a decision of Substantially Equivalent on Mar 24, 1986. The device falls under product code KGX (Tape And Bandage, Adhesive), a Class I device regulated under 21 CFR 880.5240. W.R. Grace & Co.-Conn. has 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 24, 1986
Date Received
Mar 4, 1986
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 K860804. Report a data issue: hello@regdatalab.com.