510(k) K873368

TECNOL COMPRESSION KNEE DRESSING by Tecnol New Jersey Wound Care, Inc. — Product Code LLK

K873368 is an FDA 510(k) premarket notification submitted by Tecnol New Jersey Wound Care, Inc. for the device "TECNOL COMPRESSION KNEE DRESSING". The FDA issued a decision of Substantially Equivalent on December 11, 1987. The device falls under product code LLK (Legging, Compression, Non-Inflatable), a Class II device regulated under 21 CFR 880.5780. Tecnol New Jersey Wound Care, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 1987
Date Received
August 21, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Legging, Compression, Non-Inflatable
Device Class
Class II
Regulation Number
880.5780
Review Panel
HO
Submission Type