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510(k) K974228

HOSPITAL'S SPEC by Gps — Product Code HIB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 1997
Date Received
November 12, 1997
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 Gps

  • K974227 — HOSPITAL'S CLAMP (December 12, 1997)

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