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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name set, administration, intravascular
510(k) Number K931813
Device Name NEEDLESAFE HANDGUARD
Applicant
ADRIAN ANESTHESIA SYSTEMS, INC.
3325 S. ADRIAN HIGHWAY
ADRIAN,  MI  49221
Applicant Contact MARTIN KEMPEN
Correspondent
ADRIAN ANESTHESIA SYSTEMS, INC.
3325 S. ADRIAN HIGHWAY
ADRIAN,  MI  49221
Correspondent Contact MARTIN KEMPEN
Regulation Number880.5440
Classification Product Code
FPA  
Date Received04/08/1993
Decision Date 07/22/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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