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510(k) K885220

PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT by Ethox Corp. — Product Code KNT

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
September 25, 1989
Date Received
December 20, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Gastrointestinal (And Accessories)
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

Other clearances by Ethox Corp.

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  • K962850 — TUM-E-VAC (February 21, 1997)
  • K935633 — NO-MES (September 30, 1994)
  • K921946 — TUM-E-VAC BITE BLOCK (December 9, 1992)
  • K894927 — SURGI SQUEEZ (September 11, 1989)
  • K883977 — SURGI-CUF STERILE/NON-STERILE DISPOSABLE (February 10, 1989)
  • K860599 — ETHOX LAVAGE TUBE (March 11, 1986)
  • K844988 — ETHOX NEONATAL BLOOD PRESSURE CUFF-STERILE/DISPOS. (April 4, 1985)
  • K841512 — ETHOX RELIA-FLO 2001 ENTERAL FEED (May 21, 1984)

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