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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 K881020
Device Name SURGICAL SEALANT DISPENSER (SSD)
Applicant
Micromedics, Inc.
268 E. Lafayette Frontage
Rd.
St. Paul,  MN  55107
Applicant Contact CURT MILLER
Correspondent
Micromedics, Inc.
268 E. Lafayette Frontage
Rd.
St. Paul,  MN  55107
Correspondent Contact CURT MILLER
Regulation Number880.6960
Classification Product Code
KYZ  
Date Received03/10/1988
Decision Date 03/25/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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