510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K781907Substantially Equivalent

Ear Stopples for Noise Attention

Crown Delta Corp., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K781907 is the FDA 510(k) clearance record for EAR STOPPLES FOR NOISE ATTENTION, cleared for Crown Delta Corp. on under FDA product code EWD (Protector, Hearing (Insert)). FDA records list 18 510(k) clearances for Crown Delta Corp., from to . As of , FDA records show no recalls naming K781907.

Clearance record

Decision date
Received
(8 days to decision)
Product code
EWD Protector, Hearing (Insert)
Device class
Unclassified
Review panel
Unknown
Applicant
Crown Delta Corp. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code EWD

Trailing 12 months

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

FDA records show no clearances under product code EWD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EWD, 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