510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K040491Substantially Equivalent

Chin-Up Strip

Dale Miller, Inc. - the Chin-Up Company, Dracula GA / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)

K040491 is the FDA 510(k) clearance record for CHIN-UP STRIP, a class I device, cleared for Dale Miller, Inc. - the Chin-Up Company on under FDA product code LWF (Dilator, Nasal). FDA records list one 510(k) clearance for Dale Miller, Inc. - the Chin-Up Company. As of , FDA records show no recalls naming K040491.

Clearance record

Decision date
Received
(197 days to decision)
Product code
LWF Dilator, Nasal
Regulation
21 CFR 874.3900
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Dale Miller, Inc. - the Chin-Up Company 1820 Ridgemill Ter., Dracula GA
510(k) summary
Statement
Third party review
No

Clearances, product code LWF

Trailing 12 months

FDA records hold no clearances under product code LWF in the trailing twelve months.

FDA records show no clearances under product code LWF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LWF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260