BURN DRESSING PAD— 510(k) K780418

Substantially Equivalent

The Owenby Co.

FDA 510(k) clearance K780418 for BURN DRESSING PAD, Substantially Equivalent on 1978-04-10. Applicant: The Owenby Co.. Device class: 1.

Clearance details

Applicant: The Owenby Co.
Product code: Code FPY
Device class: Class 1
Regulation: 21 CFR 880.5180
Advisory panel: General Hospital
Date received: 1978-03-14
Decision date: 1978-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Recent devices under product code FPY

K930759 — CP & S STERILE BURN SHEET1994-01-21
K921470 — BURNSHIELD FIRE BLANKET1993-04-20
K921471 — BURNSHIELD TRAUMA DRESSING1993-04-20
K926290 — BURN SHEET1993-04-20
K900441 — BURNS CASUALTY SHEET1990-07-03

More clearances from The Owenby Co.

K801628 — RESTRAINT, PROTECTIVE1980-08-07
K801532 — STOCKINETTE, STERILE TWO PLY W/PULL TABS1980-07-28
K801626 — ARM SLING1980-07-28
K801627 — COVER, LIMB1980-07-28
K801531 — ARM SLING1980-07-21

Data sourced from openFDA. This site is unofficial and independent of the FDA.