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510(k) K854812

NELSON-JUNG PLEURAL CATH by Research Medical, Inc. — Product Code GBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 1986
Date Received
December 3, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Peritoneal
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

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  • K920676 — RMI SOFCLAMP (April 15, 1992)
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  • K913733 — STERILE CHEST TUBE (October 8, 1991)
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