Home / 510(k) Clearances / K873039

510(k) K873039

MODEL 820 TOP=TRAK by Sierra Laboratories, Inc. — Product Code BYN

K873039 is an FDA 510(k) premarket notification submitted by Sierra Laboratories, Inc. for the device "MODEL 820 TOP=TRAK". The FDA issued a decision of Substantially Equivalent on February 11, 1988. The device falls under product code BYN (Chair, Posture, For Cardiac And Pulmonary Treatment), a Class I device regulated under 21 CFR 868.5365. Sierra Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 1988
Date Received
August 4, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chair, Posture, For Cardiac And Pulmonary Treatment
Device Class
Class I
Regulation Number
868.5365
Review Panel
AN
Submission Type

Other clearances by Sierra Laboratories, Inc.

  • K970966 — COMFORT CATH CHOICE MALE EXTERNAL CATHETER (April 22, 1997)
  • K962384 — COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER (July 15, 1996)
  • K962413 — COMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETER (July 15, 1996)
  • K934266 — COMFORT CATH SELF ADHERING MALE EXTERNAL CATHETER (April 19, 1994)
  • K934052 — ALPINE REUSABLE LEG BAGS (January 7, 1994)
  • K931156 — CONE CATH (July 1, 1993)
  • K901000 — URO TEX URINALS (March 26, 1990)
  • K883057 — COMFORT CATH MALE EXTERNAL CATHETER (August 2, 1988)
  • K832450 — URO-TEX MALE EXTERNAL CATHETER (October 14, 1983)
  • K811887 — SKIN STAPLE EXTRACTOR (July 27, 1981)

FDA data resources