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510(k) K874888

ISOLATION GOWN by Sage Products, Inc. — Product Code FYC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1987
Date Received
December 1, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gown, Isolation, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type

Other clearances by Sage Products, Inc.

  • K972705 — RESHEATHER DEVICE-METAL OR PLASTIC, RESHEATER/ NEEDLE HOLDER DEVICE-PLASTIC (April 30, 1998)
  • 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)

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  • K214116 — AAMI4 Isolation Gown (October 11, 2022)
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