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510(k) K791426

PERITONEAL PAC by Intermed, Inc. — Product Code KDJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 1979
Date Received
July 26, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, For Peritoneal Dialysis, Disposable
Device Class
Class II
Regulation Number
876.5630
Review Panel
GU
Submission Type

Other clearances by Intermed, Inc.

  • K900857 — NON STERILE PARENTERAL SUPPLY KIT (May 22, 1990)
  • K842166 — INTERMED, INS STERILE WATER/SALINE (February 12, 1985)
  • K833126 — DRESSING CHANGE TRAYS (January 27, 1984)
  • K833574 — PERCUTANEOUS SHEATH INTRODUCER TRAYS (January 11, 1984)
  • K833573 — CENTRAL VEIN CATH. TRAY CC-20-1420 (January 11, 1984)
  • K833139 — ACUTE HEMODIALYSIS TRAYS (December 22, 1983)
  • K833059 — SUCTION CATHETER TRAYS (December 12, 1983)
  • K821269 — TRACHEOSTOMY CARE TRAYS (May 27, 1982)
  • K791427 — CATHETERIZATION TRAYS FOLEY AND URETHRAL (September 7, 1979)
  • K781748 — IRRIGATION TRAY (December 12, 1978)

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