MEDI GUARD UNDERPAD— 510(k) K911952

Substantially Equivalent

Sancella, Inc.

FDA 510(k) clearance K911952 for MEDI GUARD UNDERPAD, Substantially Equivalent on 1991-05-28. Applicant: Sancella, Inc.. Device class: 1.

Clearance details

Applicant: Sancella, Inc.
Product code: Code KME
Device class: Class 1
Regulation: 21 CFR 880.6060
Advisory panel: General Hospital
Date received: 1991-05-01
Decision date: 1991-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canada, CA

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

More clearances from Sancella, Inc.

K911944 — MEDI GUARD DENTAL BIB1991-10-04
K911948 — MEDI GUARD PILLOWCASE1991-05-28
K911953 — MEDI GUARD SHEETS/UNDERLAYS1991-05-28
K911950 — MEDI GUARD DRAPES1991-05-21

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