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510(k) K833469

FPC FECAL PARASITE CONCENTRATOR by Evergreen Scientific, Inc. — Product Code LKS

K833469 is an FDA 510(k) premarket notification submitted by Evergreen Scientific, Inc. for the device "FPC FECAL PARASITE CONCENTRATOR". The FDA issued a decision of Substantially Equivalent on November 28, 1983. The device falls under product code LKS (Device, Parasite Concentration), a Class I device regulated under 21 CFR 866.2900. Evergreen Scientific, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 1983
Date Received
October 6, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Parasite Concentration
Device Class
Class I
Regulation Number
866.2900
Review Panel
MI
Submission Type

Other clearances by Evergreen Scientific, Inc.

  • K890134 — FTK FECAL TRANSPORT KIT (April 21, 1989)

Other clearances for product code LKS

  • K053257 — PARA-PRO FC50 (May 12, 2006)
  • K021420 — PARACON II/FECAL CONCENTRATOR II (June 4, 2002)
  • K980077 — PARA-PAK SPINCON (April 2, 1998)
  • K941110 — PARAKIT (May 17, 1994)
  • K941129 — CON-KIT (May 9, 1994)
  • K935316 — PARASAFE(R) FIXATIVE (February 17, 1994)
  • K933370 — STOOL TRANSPORT/PROCESSOR (February 17, 1994)
  • K931849 — PARAPREP (December 2, 1993)
  • K881649 — MODIFIED PARACON(TM) CONCENTRATION KIT (April 21, 1988)
  • K860034 — PARA-PAK MACRO-CON (February 21, 1986)

FDA data resources