510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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LLKClass II

Legging, Compression, Non-Inflatable

21 CFR 880.5780 / General Hospital
FDA source (opens on fda.gov)

LLK is the FDA product code for Legging, Compression, Non-Inflatable, a class II device type, regulated under 21 CFR 880.5780. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
LLK
Device name
Legging, Compression, Non-Inflatable
Regulation
21 CFR 880.5780
Device class
Class II
Review panel
General Hospital
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
1

Clearances, product code LLK

By decision year
4 clearances under product code LLK with a decision year between 1984 and 1990, 1987 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code LLK by decision year
YearClearances
19841
19872
19901

Applicants with the most clearances

Product code LLK
Applicants holding the most 510(k) clearances under product code LLK
ApplicantClearances
A-T Surgical Mfg. Co., Inc.1
Aci Medical, LLC1
Spacelabs, Inc.1
Tecnol New Jersey Wound Care, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code