510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K905519Substantially Equivalent

Montrose Dressing Applicators

Olemunda Pty, Ltd., Evans City PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K905519 is the FDA 510(k) clearance record for MONTROSE DRESSING APPLICATORS, a class I device, cleared for Olemunda Pty , Ltd. on under FDA product code NAD (Dressing, Wound, Occlusive). FDA records list one 510(k) clearance for Olemunda Pty , Ltd. As of , FDA records show no recalls naming K905519.

Clearance record

Decision date
Received
(89 days to decision)
Product code
NAD Dressing, Wound, Occlusive
Regulation
21 CFR 878.4020
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Olemunda Pty , Ltd. One Landmark N., Evans City PA
Third party review
No

Clearances, product code NAD

Trailing 12 months
1 clearance under product code NAD in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NAD, 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 20261
October 20260