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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hemostat
510(k) Number K843593
Device Name SURGIPRESS SURGICAL LOOP
Applicant
SYNTEX CORP.
3401 HILLVIEW AVE.
PALO ALTO,  CA  94304
Applicant Contact JEAN STRAND
Correspondent
SYNTEX CORP.
3401 HILLVIEW AVE.
PALO ALTO,  CA  94304
Correspondent Contact JEAN STRAND
Regulation Number878.4800
Classification Product Code
HRQ  
Date Received09/12/1984
Decision Date 10/24/1984
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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