Atlas FDA

KBF

1 FDA 510(k) clearances · Product code

FDA profile

Official device name
Trephine, Sinus
Device class
Class I (low risk)
Regulation
21 CFR 874.4420
Medical specialty
Ear, Nose, Throat
Adverse events (MAUDE)
1999: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
MONTG. TRACHEAL TREPHINE FENE STRATOR (K802915)Boston Medical Products, Inc.1980-12-19

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