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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laryngoscope, Rigid
510(k) Number K953179
Device Name CLM LARYNGOSCOPE
Applicant
PENLON LTD.
RADLEY ROAD
AINGDON
OXONN,  GB OX14 3PH
Applicant Contact A. C. GREEN
Correspondent
PENLON LTD.
RADLEY ROAD
AINGDON
OXONN,  GB OX14 3PH
Correspondent Contact A. C. GREEN
Regulation Number868.5540
Classification Product Code
CCW  
Date Received07/10/1995
Decision Date 10/06/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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