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510(k) K823331

PC-204 TUNNELOR by Medigroup — Product Code FKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1983
Date Received
November 8, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Peritoneal, Automatic Delivery
Device Class
Class II
Regulation Number
876.5630
Review Panel
GU
Submission Type

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  • K823293 — MEDIGROUP LG-102 LIGHT GUIDE (May 5, 1983)

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