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510(k) K913575

GAUZE PACKING, SURGICAL STERILE AND NON-STERILE by Keilei Intl., Inc. — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 1991
Date Received
August 12, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Keilei Intl., Inc.

  • K913779 — BANDAGE ROLL, GAUZE (December 4, 1991)
  • K912779 — GAUZE SPONGE,STERILE 2'S (September 30, 1991)
  • K895372 — X-RAY DETECTABLE GAUZE SPONGE (November 3, 1989)
  • K895086 — GAUZE SPONGE (October 23, 1989)

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