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510(k) K955433

DURALASTIC SILICONE TUBING by Allied Biomedical Corp. — Product Code KGZ

K955433 is an FDA 510(k) premarket notification submitted by Allied Biomedical Corp. for the device "DURALASTIC SILICONE TUBING". The FDA issued a decision of Substantially Equivalent on January 26, 1996. The device falls under product code KGZ (Accessories, Catheter), a Class I device regulated under 21 CFR 878.4200. Allied Biomedical Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1996
Date Received
November 28, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Catheter
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

Other clearances by Allied Biomedical Corp.

  • K982051 — KELOCATE SHEETING (August 5, 1998)
  • K971478 — DURALASTIC ANATOMICAL CHIN IMPLANTS (July 18, 1997)
  • K971479 — DURALASTIC ANATOMICAL MALAR IMPLANTS (July 18, 1997)
  • K971481 — DURALASTIC ANATOMICAL NASAL IMPLANTS (July 18, 1997)
  • K971480 — DURALASTIC I AND DURALASTIC II (May 28, 1997)
  • K955370 — DURALASTIC II (February 8, 1996)
  • K955368 — DURALASTIC I (February 8, 1996)
  • K954413 — KELOCOTE (November 29, 1995)

Other clearances for product code KGZ

  • K022306 — AART SILICONE TUBING (October 10, 2002)
  • K974295 — BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING (February 10, 1998)
  • K973183 — WOUND DRAINAGE HOLDER (January 23, 1998)
  • K942315 — NAVARRE PERCUTANEOUS ACCESS SET (July 8, 1994)
  • K896087 — PALESTRANT IRRIGATION AND DRAINAGE SET (November 3, 1989)
  • K895041 — OPTICAL CATHETER(TM) INTRODUCER SETS (October 16, 1989)
  • K893406 — DESERET PRN ADAPTER (June 22, 1989)
  • K873009 — CONCEPT SWITCHING STICK (August 17, 1987)
  • K870014 — HCI GENERAL PURPOSE CATHETER STYLET (February 6, 1987)
  • K864115 — TUBEGRIPPER, DRAINAGE CATHETER & ACCESSORY FOR SU (November 7, 1986)

FDA data resources