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510(k) K934610

CATH DOME PD- WATER RESISTANT COVER FOR INDWELLING PERITONEAL DIALYSIS CATHETERS AND TRANSFER SETS by Tabex Industries, Inc. — Product Code FJS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1994
Date Received
September 27, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Peritoneal, Long-Term Indwelling
Device Class
Class II
Regulation Number
876.5630
Review Panel
GU
Submission Type

Other clearances by Tabex Industries, Inc.

  • K930175 — CATH BELT PD CATHETER AND TRANSFER SET HOLDER (June 23, 1994)

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