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

Support Gels

21 CFR 866.4900 / Immunology
FDA source (opens on fda.gov)

JZR is the FDA product code for Support Gels, a class I device type, regulated under 21 CFR 866.4900. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JZR
Device name
Support Gels
Regulation
21 CFR 866.4900
Device class
Class I
Review panel
Immunology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code JZR

By decision year
2 clearances under product code JZR with a decision year between 1983 and 1995, 1983 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code JZR by decision year
YearClearances
19831
19951

Applicants with the most clearances

Product code JZR
Applicants holding the most 510(k) clearances under product code JZR
ApplicantClearances
Fmc Corp.1
Helena Laboratories, Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code