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510(k) K895848

PRESSURE STEAM STERILIZERS by Scientific Device Laboratory, Inc. — Product Code FLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 1989
Date Received
October 3, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer, Steam
Device Class
Class II
Regulation Number
880.6880
Review Panel
HO
Submission Type

Other clearances by Scientific Device Laboratory, Inc.

  • K935316 — PARASAFE(R) FIXATIVE (February 17, 1994)
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  • K911059 — TURBIDOMETRIC STANDARD (June 10, 1991)
  • K890670 — CRYPTOSPORIDIUM CONTROL SLIDE (March 16, 1989)
  • K890718 — GRAM STAIN CONTROL SLIDE (March 16, 1989)
  • K884069 — SNAP N' STAIN IODINE STAIN (October 25, 1988)
  • K884011 — SNAP N' STAIN IRON STAIN (October 6, 1988)
  • K883052 — METHENO-STAIN KIT (August 30, 1988)
  • K881598 — SDL TRICHROME STAIN (May 4, 1988)
  • K840506 — HAEMOPHILUS INFLUENZAE TYPE B (April 4, 1984)

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