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510(k) K022948

VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555L by Medical Action Industries, Inc. — Product Code HIB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 2002
Date Received
September 5, 2002
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

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  • K946019 — SURGICLA INSTRUMENT KIT (March 20, 1995)
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  • K884826 — GAUZE SPONGE (December 22, 1988)
  • K810685 — SUTURE REMOVAL KIT (March 26, 1981)
  • K810184 — LAPAROTOMY SPONGE (February 4, 1981)

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