FDA 510(k) Application Details - K990220

Device Classification Name Kit, Needle, Biopsy

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510(K) Number K990220
Device Name Kit, Needle, Biopsy
Applicant MEDI-GLOBE CORP.
6202 SOUTH MAPLE AVE. # 131
TEMPE, AZ 85283 US
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Contact MICHELLE L FIELDS
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Regulation Number 876.1075

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Classification Product Code FCG
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Date Received 01/22/1999
Decision Date 03/31/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K990220


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