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510(k) K873360

ENTERON PERCUTAN. ENDOSCOPIC GASTROSTOMY TRAY-PEG by Endovations — Product Code KNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 1988
Date Received
August 21, 1987
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

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  • K913841 — 2 LUMEN ENDOS RETRO CHOLANGIOPANCREA INJEC CATH (October 8, 1991)
  • K913870 — 5MM MICROSCISSORS (September 16, 1991)
  • K911155 — OVAL CUP BIOPSY FORCEP (August 7, 1991)
  • K892218 — ENDO-SPONGE (May 31, 1989)
  • K883093 — TRANSENDOSCOPIC ASPIRATION NEEDLE (December 8, 1988)
  • K875264 — WASHING CATHETER (March 29, 1988)

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