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

System/Device, Pharmacy Compounding

21 CFR 880.5440 / General Hospital
FDA source (opens on fda.gov)

NEP is the FDA product code for System/Device, Pharmacy Compounding, a class II device type, regulated under 21 CFR 880.5440. As of , FDA records hold no 510(k) clearances under this code and 41 recalls.

Classification record

Product code
NEP
Device name
System/Device, Pharmacy Compounding
Regulation
21 CFR 880.5440
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
0
Ingested recalls
41

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 38 companies shown, in name order