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510(k) K042950

VAG O SPECULUM, MODELS VS1, VM1, VL1 by Panatrex, Inc. — Product Code HIB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 2004
Date Received
October 26, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Speculum, Vaginal, Nonmetal
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

Other clearances by Panatrex, Inc.

  • K982578 — QUANTI-TEST SYSTEM (September 2, 1998)

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