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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name syringe, irrigating (non dental)
510(k) Number K883338
Device Name SURGICAL SEALANT APPLICATOR
Applicant
MICROMEDICS, INC.
268 E. LAFAYETTE FRONTAGE
ROAD
ST. PAUL,  MN  55107
Applicant Contact CURTIS H MILLER
Correspondent
MICROMEDICS, INC.
268 E. LAFAYETTE FRONTAGE
ROAD
ST. PAUL,  MN  55107
Correspondent Contact CURTIS H MILLER
Regulation Number880.6960
Classification Product Code
KYZ  
Date Received08/09/1988
Decision Date 08/23/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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