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510(k) K873200

KARLSON OZONE STERILIZER MODEL 100B by Life Enhancement Technologies, LLC — Product Code FLF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 1989
Date Received
August 13, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer, Ethylene-Oxide Gas
Device Class
Class II
Regulation Number
880.6860
Review Panel
HO
Submission Type

Other clearances by Life Enhancement Technologies, LLC

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  • K051595 — TSO3 OZONE STERILIZER, MODEL 125L (July 26, 2006)
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  • K023290 — STERRAD 50 & STERRAD 100S STERILIZERS (April 3, 2003)
  • K905119 — PLAZLYTE(TM) (December 22, 1994)