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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name kit, surgical instrument, disposable
510(k) Number K924958
Device Name BIOPSY/MYELO/ARTHRO/AMNIOCENT/BASIC SKIN PREP TRAY
Applicant
MEDICAL INSIGHTS, INC.
193 WHITEHALL AVE.
MYSTIC,  CT  06355
Applicant Contact CARL G BARSANTI
Correspondent
MEDICAL INSIGHTS, INC.
193 WHITEHALL AVE.
MYSTIC,  CT  06355
Correspondent Contact CARL G BARSANTI
Regulation Number878.4800
Classification Product Code
KDD  
Date Received09/30/1992
Decision Date 06/07/1993
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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