510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K904389Substantially Equivalent

Si-Pro

David F. Trungale, Brookfield WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904389 is the FDA 510(k) clearance record for SI-PRO, a class I device, cleared for David F. Trungale on under FDA product code EYF (Protector, Wound, Plastic). FDA records list one 510(k) clearance for David F. Trungale. As of , FDA records show no recalls naming K904389.

Clearance record

Decision date
Received
(82 days to decision)
Product code
EYF Protector, Wound, Plastic
Regulation
21 CFR 878.4014
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
David F. Trungale 16720 Rosewood Ct., Brookfield WI
Third party review
No

Clearances, product code EYF

Trailing 12 months

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

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