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

Drills, Burrs, Trephines, And Accessories (Powered Compound), Reprocessed

21 CFR 882.4305 / Neurology
FDA source (opens on fda.gov)

NLP is the FDA product code for Drills, Burrs, Trephines, And Accessories (Powered Compound), Reprocessed, a class II device type, regulated under 21 CFR 882.4305. FDA's definition for this code reads: "Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
NLP
Device name
Drills, Burrs, Trephines, And Accessories (Powered Compound), Reprocessed
FDA definition
Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Regulation
21 CFR 882.4305
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

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