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

Stimulator, Neuromuscular, Implanted

21 CFR 882.5860 / Neurology
FDA source (opens on fda.gov)

GZC is the FDA product code for Stimulator, Neuromuscular, Implanted, a class III device type, regulated under 21 CFR 882.5860. FDA's definition for this code reads: "Call for PMAs to be filed by 7/13/99 per 64 FR 18329 on 4/14/99". As of , FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code
GZC
Device name
Stimulator, Neuromuscular, Implanted
FDA definition
Call for PMAs to be filed by 7/13/99 per 64 FR 18329 on 4/14/99
Regulation
21 CFR 882.5860
Device class
Class III
Review panel
Neurology
Submission type
PMA
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code GZC.