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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 K001615
Device Name HUNTER SCIENTIFIC INJECTION PIPETTES
Applicant
Hunter Scientific Limited
Unit 1, Priors Hall,
Widdington
Saffron Walden, Essex,  GB CB113SB
Applicant Contact MARK RAWE
Correspondent
Hunter Scientific Limited
Unit 1, Priors Hall,
Widdington
Saffron Walden, Essex,  GB CB113SB
Correspondent Contact MARK RAWE
Regulation Number884.6130
Classification Product Code
MQH  
Date Received05/25/2000
Decision Date 08/18/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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