FDA 510(k) Application Details - K000026

Device Classification Name Curette, Suction, Endometrial (And Accessories)

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510(K) Number K000026
Device Name Curette, Suction, Endometrial (And Accessories)
Applicant APPLE MEDICAL CORP.
28 LORD RD., UNIT 135
MARLBORO, MA 01752 US
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Contact JOHN PULFORD
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Regulation Number 884.1175

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Classification Product Code HHK
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Date Received 01/05/2000
Decision Date 03/31/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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