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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 K921263
Device Name SUNLITE LARYNGOSCOPE
Applicant
Sunmed, Inc.
5401 Tech Data Dr.
Clearwater,  FL  34620
Applicant Contact GEORGE CRANTON
Correspondent
Sunmed, Inc.
5401 Tech Data Dr.
Clearwater,  FL  34620
Correspondent Contact GEORGE CRANTON
Regulation Number868.5540
Classification Product Code
CCW  
Date Received03/16/1992
Decision Date 06/01/1993
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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