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510(k) K893522

SURGEON'S GLOVES by Thai Fuji Latex Co., Ltd. — Product Code FGO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1990
Date Received
May 8, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dislodger, Stone, Flexible
Device Class
Class II
Regulation Number
876.4680
Review Panel
GU
Submission Type

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  • K921295 — INTRAVENOUS CATHETERS MODIFICATIONS (May 17, 1993)
  • K922542 — GRASPING FORCEPS (August 19, 1992)
  • K914112 — METAL URETERAL BASKET STONE DISLODGER, FLAT WIRE (February 28, 1992)