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510(k) K993528

RUSCH EMERGENCY MASK by Rusch, Inc. — Product Code CBP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 2000
Date Received
October 18, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Valve, Non-Rebreathing
Device Class
Class II
Regulation Number
868.5870
Review Panel
AN
Submission Type

Other clearances by Rusch, Inc.

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  • K993194 — RUSCH MANUAL RESUSCITATOR BAG (March 24, 2000)
  • K980870 — RUSCH SILICONE FOLEY CATHETER (June 9, 1998)
  • K974419 — RUSCH SIMPLASTIC COUNCILL TIP CATHETER (January 27, 1998)
  • K963779 — RUSCH ENTERAL FEEDING TUBE (May 23, 1997)
  • K970021 — RUSCH SUPRAPUBIC TRAY (February 7, 1997)
  • K963993 — RUSCH SIMPLASTIC FOLEY CATHETERIZATION SET (December 17, 1996)
  • K955564 — RUSCH ULTRA TRACHEOFLEX TRACHEOSTOMY SET, CUFFED, STERILE (June 28, 1996)
  • K955495 — RUSCH REINFORCED TRACHAEL TUBE CUFFED, STERILE (June 27, 1996)
  • K953963 — RUSCH SINGLE LUMEN BRONCHIAL TUVBE SET, STERILE, FOR LEFT & RIGHT SIDED BRONCHIA (November 27, 1995)

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