ROSEALAE— 510(k) K782001

Substantially Equivalent

Asmb

FDA 510(k) clearance K782001 for ROSEALAE, Substantially Equivalent on 1978-12-07. Applicant: Asmb. Device class: 1.

Clearance details

Applicant: Asmb
Product code: Code KME
Device class: Class 1
Regulation: 21 CFR 880.6060
Advisory panel: General Hospital
Date received: 1978-12-04
Decision date: 1978-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KME

K042145 — READY-HEAT BLANKET2004-09-17
K944953 — OREX MEDICAL BEDDING1994-12-02
K933636 — DISPOSE-A-SHEET1994-01-26
K932539 — DOCTOR DOWN --RESCUE WRAP1993-11-02
K922143 — AMERICAN BURN SHEET1992-08-10

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