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510(k) K953610

AUKULYTE by Aukland Medical Plastics, Inc. — Product Code KPY

K953610 is an FDA 510(k) premarket notification submitted by Aukland Medical Plastics, Inc. for the device "AUKULYTE". The FDA issued a decision of Substantially Equivalent on September 26, 1995. The device falls under product code KPY (Shield, Protective, Personnel), a Class I device regulated under 21 CFR 892.6500. Aukland Medical Plastics, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1995
Date Received
August 2, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shield, Protective, Personnel
Device Class
Class I
Regulation Number
892.6500
Review Panel
RA
Submission Type

Other clearances by Aukland Medical Plastics, Inc.

  • K930840 — POST-MYDS(TM) (March 1, 1994)
  • K930094 — AUKUSLEEVE (October 20, 1993)

Other clearances for product code KPY

  • K110900 — DISPOSABLE THYROID COLLAR (June 24, 2011)
  • K962622 — INTRA-ORAL THERMOPLASTIC SHIELD (October 1, 1996)
  • K954456 — THERMOPLASTIC SHIELD (December 21, 1995)
  • K954146 — UTK-DTE AUTILARY SHIELD (December 6, 1995)
  • K951004 — 2001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4) (April 10, 1995)
  • K951003 — KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5) (April 3, 1995)
  • K940539 — STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM (March 16, 1994)
  • K934206 — MAVIG ANGIO SHIELD MODELS 6290 & 6272 (October 7, 1993)
  • K912378 — DAVIS LEAD APRON/RADIOGRAPHIC VARIOUS CAT. NUMBERS (March 18, 1992)
  • K912326 — DAVIS LEAD APRON - VARIOUS CATALOGUE NUMBERS (March 18, 1992)

FDA data resources