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510(k) K833554

MATERIAL ADDITION LEXAN & K-RESIN by Procedure Products, Inc. — Product Code DQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1984
Date Received
October 5, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Diagnostic
Device Class
Class II
Regulation Number
870.1200
Review Panel
CV
Submission Type

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  • K853749 — CUSTOM CORONARY MANIFOLD KITS (January 13, 1986)
  • K842173 — DISPOSABLE STOPCOCKS (September 5, 1984)

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