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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 K801452
Device Name OROTRACHEAL INTUBATION ENDOSCOPE
Applicant
Olympus Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Olympus Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number868.5540
Classification Product Code
CCW  
Date Received06/23/1980
Decision Date 07/14/1980
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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