Home / 510(k) Clearances / K972705

510(k) K972705

RESHEATHER DEVICE-METAL OR PLASTIC, RESHEATER/ NEEDLE HOLDER DEVICE-PLASTIC by Sage Products, Inc. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 1998
Date Received
July 21, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

Other clearances by Sage Products, Inc.

  • K980490 — SAGE PRODUCTS INC, SHARPS DISPOSAL CONTAINERS WITH SCREW TOP CAPS (February 24, 1998)
  • K973911 — 2 GALLON ALTERNATE CARE SHARPS CONTAINER (October 29, 1997)
  • K972279 — SHARPS SHUTTLE (August 29, 1997)
  • K970135 — NITRILE GLOVES (August 25, 1997)
  • K972302 — POCKET COUNT OR SAFETCOUNT (July 25, 1997)
  • K964168 — PROCEDURE SPECIFIC KITS (March 3, 1997)
  • K963986 — STP SYSTEM PVA WITH ZINC (November 8, 1996)
  • K964026 — STP SYSTEM - SAF (November 7, 1996)
  • K964027 — STP SYSTEM-PVA WITH MERCURY (November 1, 1996)
  • K962168 — MUCUS SPECIMEN TRAP (July 22, 1996)

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