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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 K896205
Device Name MONOSCOPY BRAND, 5 MM LOCKING TROCAR SLEEVE
Applicant
DEXIDE, INC.
P.O. BOX 185789
FT. WORTH,  TX  76181
Applicant Contact MILLER, R.N.
Correspondent
DEXIDE, INC.
P.O. BOX 185789
FT. WORTH,  TX  76181
Correspondent Contact MILLER, R.N.
Regulation Number876.1500
Classification Product Code
GCI  
Date Received10/26/1989
Decision Date 03/22/1990
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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