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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Microtools, Assisted Reproduction (Pipettes)
510(k) Number K991700
Device Name SWEMED INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES; HOLDING PIPTTES; DENUDING PIPETTES; ASSISTED/ZO
Applicant
Swemed Lab International AB
Billdalsvagen 2
Billdal,  SE SE-427 36
Applicant Contact EDWARD C WILSON
Correspondent
Swemed Lab International AB
Billdalsvagen 2
Billdal,  SE SE-427 36
Correspondent Contact EDWARD C WILSON
Regulation Number884.6130
Classification Product Code
MQH  
Date Received05/18/1999
Decision Date 07/19/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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