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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 K933515
Device Name BOOTY ENDOSCOPE WARMER
Applicant
T-MED, INC.
P.O. BOX 16598
FT. WORTH,  TX  76162 -0598
Applicant Contact CHERYL A BOYCE
Correspondent
T-MED, INC.
P.O. BOX 16598
FT. WORTH,  TX  76162 -0598
Correspondent Contact CHERYL A BOYCE
Regulation Number876.1500
Classification Product Code
GCI  
Date Received07/20/1993
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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