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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 K844823
Device Name MICROINFERTILITY FORCEPS, TITANIUM
Applicant
Precision Surgical Instrument, Inc.
83 E. Water St., Box 35
Rockland,  MA  02370
Applicant Contact KATHLEEN M FEENEY
Correspondent
Precision Surgical Instrument, Inc.
83 E. Water St., Box 35
Rockland,  MA  02370
Correspondent Contact KATHLEEN M 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
Predetermined Change
Control Plan Authorized		 No
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