510(k) K810137

SOF-BAND HIGH STRETCH BANDAGES by Johnson & Johnson Professionals, Inc. — Product Code FQM

K810137 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Professionals, Inc. for the device "SOF-BAND HIGH STRETCH BANDAGES". The FDA issued a decision of Substantially Equivalent on February 17, 1981. The device falls under product code FQM (Bandage, Elastic), a Class I device regulated under 21 CFR 880.5075. Johnson & Johnson Professionals, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 1981
Date Received
January 21, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bandage, Elastic
Device Class
Class I
Regulation Number
880.5075
Review Panel
HO
Submission Type