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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K940141
Device Name LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH
Applicant
MICRO-MEDICAL DEVICES, INC.
317 PARAGON WAY
CASTLE ROCK,  CO  80104
Applicant Contact EDWIN L ADAIR, M.D.
Correspondent
MICRO-MEDICAL DEVICES, INC.
317 PARAGON WAY
CASTLE ROCK,  CO  80104
Correspondent Contact EDWIN L ADAIR, M.D.
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received01/11/1994
Decision Date 05/19/1994
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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