AUKULYTE— 510(k) K953610

Substantially Equivalent

Aukland Medical Plastics, Inc.

FDA 510(k) clearance K953610 for AUKULYTE, Substantially Equivalent on 1995-09-26. Applicant: Aukland Medical Plastics, Inc.. Device class: 1.

Clearance details

Applicant: Aukland Medical Plastics, Inc.
Product code: Code KPY
Device class: Class 1
Regulation: 21 CFR 892.6500
Advisory panel: Radiology
Date received: 1995-08-02
Decision date: 1995-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cary, NC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KPY

K110900 — DISPOSABLE THYROID COLLAR2011-06-24
K962622 — INTRA-ORAL THERMOPLASTIC SHIELD1996-10-01
K954456 — THERMOPLASTIC SHIELD1995-12-21
K954146 — UTK-DTE AUTILARY SHIELD1995-12-06
K951004 — 2001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4)1995-04-10

More clearances from Aukland Medical Plastics, Inc.

K930840 — POST-MYDS(TM)1994-03-01
K930094 — AUKUSLEEVE1993-10-20

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