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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, adhesive, external
510(k) Number K790946
Device Name GORDON IVS INTRAVENOUS STABILIZER
Applicant
WHITMAN MEDICAL CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
WHITMAN MEDICAL CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.3750
Classification Product Code
GBJ  
Date Received05/18/1979
Decision Date 06/05/1979
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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