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U.S. Department of Health and Human Services

510(K) Premarket Notification
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Device Name
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Applicant
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510(K)
Number
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Decision
Date
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endocervical block needle WALLACH SURGICAL DEVICES, INC. k021224 07/12/2002
rapido guiding catheter, 6f model# 6776; rapido guiding catheter, 8f model# 6775, 6777, 6778, 6779, 6780, 6781, 6782, GUIDANT CORP. k021455 08/02/2002
pan-america hyperbarics hyperbaric chamber system, model pah-m3+1 PAN-AMERICA HYPERBARICS, INC. k021690 10/24/2002
equalizer balloon catheter BOSTON SCIENTIFIC CORP. k021721 06/20/2002
chroloy NEIRYNCK & VOGT NV k021969 07/30/2002
modification to symphony graft delivery system DEPUY ACROMED k022246 08/02/2002
uterine injector THOMAS MEDICAL, INC. k022503 10/25/2002
pdo (polydioxanone) monofilament synthetic absorbable suture u.s.p. ARC MEDICAL SUPPLIES (BEIJING) CO, LTD. k022666 10/09/2002
reprocessed used disposable hot and cold biopsy forceps MEDICAL DEVICE SERVICES k022751 11/04/2002
modification to synchron systems benzodiazepine reagent BECKMAN COULTER, INC. k023048 11/07/2002

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