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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilizer, Ethylene-Oxide Gas
510(k) Number K873200
Device Name KARLSON OZONE STERILIZER MODEL 100B
Applicant
Life Enhancement Technologies, LLC
2926 State St.
Erie,  PA  16508
Applicant Contact ESKIL L KARLSON
Correspondent
Life Enhancement Technologies, LLC
2926 State St.
Erie,  PA  16508
Correspondent Contact ESKIL L KARLSON
Regulation Number880.6860
Classification Product Code
FLF  
Date Received08/13/1987
Decision Date 01/27/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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