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510(k) K861590

WEC-KLEEN, CATALOG N. 850-102 by Palmetto Chemical & Supply Co., Inc. — Product Code FLG

K861590 is an FDA 510(k) premarket notification submitted by Palmetto Chemical & Supply Co., Inc. for the device "WEC-KLEEN, CATALOG N. 850-102". The FDA issued a decision of Substantially Equivalent on June 17, 1986. The device falls under product code FLG (Cleaner, Ultrasonic, Medical Instrument), a Class I device regulated under 21 CFR 880.6150. Palmetto Chemical & Supply Co., Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 1986
Date Received
April 29, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cleaner, Ultrasonic, Medical Instrument
Device Class
Class I
Regulation Number
880.6150
Review Panel
HO
Submission Type

Other clearances by Palmetto Chemical & Supply Co., Inc.

  • K861592 — WEC-WASH, CATALOG NO. 850-115 (June 17, 1986)
  • K861588 — WECK INSTRUMENT CLEANER, CAT. NO. 850-103 (June 17, 1986)
  • K861589 — WECK-KREEM, CATALOG NO. 850-155 (May 23, 1986)
  • K861591 — WECK-LUBE, CATALOG NO. 850-150 (May 23, 1986)
  • K861587 — WECK CONCENTRATED LIQUID CLEANER (May 19, 1986)

Other clearances for product code FLG

  • K944950 — KLENZYME (December 20, 1994)
  • K944494 — ALSA-KLENZ (October 19, 1994)
  • K944033 — BILL EVANS-KLENZ (October 7, 1994)
  • K940263 — NPH-KLENZ (May 18, 1994)
  • K941163 — MON-KLENZ (May 18, 1994)
  • K935063 — INSTRU KLENZ (May 9, 1994)
  • K934666 — PDS ULTRACLEAN (April 15, 1994)
  • K931270 — SURGICLEAN ENZYMATIC INSTRUMENT CLEANER (April 13, 1994)
  • K933149 — INSTRUMENT DETERGENT CONCENTRATE (February 16, 1994)
  • K884660 — BIOSONIC ULTRASONIC CLEANING SYSTEM (March 16, 1989)

FDA data resources