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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name curette, suction, endometrial (and accessories)
510(k) Number K000026
Device Name APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER
Applicant
APPLE MEDICAL CORP.
28 LORD RD., UNIT 135
MARLBORO,  MA  01752
Applicant Contact JOHN PULFORD
Correspondent
APPLE MEDICAL CORP.
28 LORD RD., UNIT 135
MARLBORO,  MA  01752
Correspondent Contact JOHN PULFORD
Regulation Number884.1175
Classification Product Code
HHK  
Date Received01/05/2000
Decision Date 03/31/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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