510(k) K831551

COMPRESSOGRIP TUBULAR ELASTIC BANDAGE by Fred Sammons, Inc. — Product Code FQM

K831551 is an FDA 510(k) premarket notification submitted by Fred Sammons, Inc. for the device "COMPRESSOGRIP TUBULAR ELASTIC BANDAGE". The FDA issued a decision of Substantially Equivalent on June 7, 1983. The device falls under product code FQM (Bandage, Elastic), a Class I device regulated under 21 CFR 880.5075. Fred Sammons, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 1983
Date Received
May 12, 1983
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