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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name needle, catheter
510(k) Number K900374
Device Name ADAIR/VERESS NEEDLE INTRODUCER SET
Applicant
MEDICAL DYNAMICS, INC.
99 INVERNESS DR., EAST
ENGLEWOOD,  CO  80112
Applicant Contact JO BREHM
Correspondent
MEDICAL DYNAMICS, INC.
99 INVERNESS DR., EAST
ENGLEWOOD,  CO  80112
Correspondent Contact JO BREHM
Regulation Number878.4200
Classification Product Code
GCB  
Date Received01/26/1990
Decision Date 04/20/1990
Decision Substantially Equivalent (SESE)
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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