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510(k) K820672

HASSON BUEC-3 by Bivona Medical Technologies — Product Code HDP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1982
Date Received
March 11, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Elevator, Uterine
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

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  • K920604 — BIVONA TRACHEAL T-TUBE STENT (July 27, 1992)
  • K915761 — BIVONA-COLORADO VOICE PROSTHESIS (June 29, 1992)

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