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510(k) K111441

UNIMAX VERESS NEEDLE by Unimax Medical Systems, Inc. — Product Code HIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2011
Date Received
May 24, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Insufflator, Laparoscopic
Device Class
Class II
Regulation Number
884.1730
Review Panel
OB
Submission Type

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  • K103509 — UNIMAX SUCTION IRRIGATION SET (May 19, 2011)
  • K103510 — UNIMAX SPECIMEN RETRIEVAL SYSTEM (May 6, 2011)

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