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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name instrument, manual, specialized obstetric-gynecologic
510(k) Number K844821
Device Name MICROINFERTILITY NEEDLE HOLDER, TITANIUM
Applicant
PRECISION SURGICAL INSTRUMENT, INC.
83 EAST WATER ST., BOX 35
ROCKLAND,  MA  02370
Applicant Contact MI FEENEY
Correspondent
PRECISION SURGICAL INSTRUMENT, INC.
83 EAST WATER ST., BOX 35
ROCKLAND,  MA  02370
Correspondent Contact MI FEENEY
Regulation Number884.4530
Classification Product Code
KNA  
Date Received12/10/1984
Decision Date 01/16/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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