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510(k) K931270

SURGICLEAN ENZYMATIC INSTRUMENT CLEANER by Surgicot, Inc. — Product Code FLG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 1994
Date Received
March 8, 1993
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

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  • K840541 — NEURO SPONGE (April 23, 1984)
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  • K840470 — SURGISCRIBE MARKING PEN (March 12, 1984)
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Other clearances for product code FLG

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  • K944494 — ALSA-KLENZ (October 19, 1994)
  • K944033 — BILL EVANS-KLENZ (October 7, 1994)
  • K941163 — MON-KLENZ (May 18, 1994)
  • K940263 — NPH-KLENZ (May 18, 1994)
  • K935063 — INSTRU KLENZ (May 9, 1994)
  • K934666 — PDS ULTRACLEAN (April 15, 1994)
  • K933149 — INSTRUMENT DETERGENT CONCENTRATE (February 16, 1994)
  • K884660 — BIOSONIC ULTRASONIC CLEANING SYSTEM (March 16, 1989)
  • K862282 — RAPIDEX BIOLOGICAL SURFACTANT (May 11, 1987)