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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 K951147
Device Name LEIGH MED. TECH. LARYNGOSCOPE BLADE COVER
Applicant
Leigh Med Tech, Inc.
83 Weldon Pkwy.
Maryland Heights,  MO  63043
Applicant Contact JAMES TAYLOR
Correspondent
Leigh Med Tech, Inc.
83 Weldon Pkwy.
Maryland Heights,  MO  63043
Correspondent Contact JAMES TAYLOR
Regulation Number868.5540
Classification Product Code
CCW  
Date Received03/13/1995
Decision Date 06/08/1995
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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