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510(k) K895080

SURGICAL GLOVES by Jet Far Industries, Inc. — Product Code FGO

K895080 is an FDA 510(k) premarket notification submitted by Jet Far Industries, Inc. for the device "SURGICAL GLOVES". The FDA issued a decision of Substantially Equivalent on January 24, 1990. The device falls under product code FGO (Dislodger, Stone, Flexible), a Class II device regulated under 21 CFR 876.4680.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1990
Date Received
August 14, 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

Other clearances for product code FGO

  • K001563 — SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET (November 22, 2000)
  • K970121 — STONE DISLODGER, BASKET (April 2, 1997)
  • K963750 — RETRIEVAL SNARE (November 22, 1996)
  • K962676 — DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICE (October 4, 1996)
  • K951309 — STONE DISLODGER, BASKET (May 17, 1995)
  • K933261 — GRASPING FORCEPS (January 11, 1994)
  • K934598 — GRASPING FORCEPS OR RETRIEVAL FORCEPS (January 7, 1994)
  • K921295 — INTRAVENOUS CATHETERS MODIFICATIONS (May 17, 1993)
  • K922542 — GRASPING FORCEPS (August 19, 1992)
  • K914110 — GRASPING FORCEPS (February 28, 1992)

FDA data resources