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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vaporizer, Anesthesia, Non-Heated
510(k) Number K961468
Device Name QUIK-FIL VAPORIZER KEYED FILLER
Applicant
PENLON LTD.
ABINGDON
OXFORDSHIRE,  GB OX14 3PH
Applicant Contact ALAN C GREEN
Correspondent
PENLON LTD.
ABINGDON
OXFORDSHIRE,  GB OX14 3PH
Correspondent Contact ALAN C GREEN
Regulation Number868.5880
Classification Product Code
CAD  
Date Received04/17/1996
Decision Date 07/16/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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