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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 Rd.
Aingdon
Oxonn,  GB OX14 3PH
Applicant Contact A. C. GREEN
Correspondent
Penlon , Ltd.
Radley Rd.
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
Predetermined Change
Control Plan Authorized		 No
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