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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laryngoscope, endoscope
510(k) Number K930302
Device Name BIRTCHER SURE CLEAN INSTRUMENT SYSTEM
Applicant
BIRTCHER MEDICAL SYSTEMS, INC.
4775 RIVER GREEN PKWY.
DULUTH,  GA  30092
Applicant Contact EILEEN M ANDERSON
Correspondent
BIRTCHER MEDICAL SYSTEMS, INC.
4775 RIVER GREEN PKWY.
DULUTH,  GA  30092
Correspondent Contact EILEEN M ANDERSON
Regulation Number876.1500
Classification Product Code
GCI  
Date Received01/21/1993
Decision Date 10/27/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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