LYOSHEET SURGICAL SHEET FOR BURNS— 510(k) K871740

Name: FDA 510(k) clearance K871740
Creator: U.S. Food and Drug Administration
Published: 1987-06-09

Substantially Equivalent

Acme United Corp.

FDA 510(k) clearance K871740 for LYOSHEET SURGICAL SHEET FOR BURNS, Substantially Equivalent on 1987-06-09. Applicant: Acme United Corp.. Device class: 1.

Clearance details

Applicant: Acme United Corp.
Product code: Code FPY
Device class: Class 1
Regulation: 21 CFR 880.5180
Advisory panel: General Hospital
Date received: 1987-05-05
Decision date: 1987-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fairfield, CT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FPY

view all

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 Acme United Corp.

view all

K961323 — LYOFOAM EXTRA C ODOR ABSORBING WOUND DRESSING1996-06-19
K961452 — LYOFOAM EXTRA 'A' STERILE ADHESIVE WOUND DRESSING1996-05-31
K952565 — LYOFOAM EXTRA1995-11-14
K895764 — MODIFIED LYOFOAM WOUND DRESSINGS1990-09-10
K864084 — LYOFOAM C ODOR-ABSORBING DRESSING1986-11-21

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