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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope, Ac-Powered And Accessories
510(k) Number K790071
Device Name ENDOSCOPE AND ACCESSORIES
Applicant
Olympus Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Olympus Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number876.1500
Classification Product Code
GCP  
Date Received01/11/1979
Decision Date 04/02/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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