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510(k) K960492

SI CONTROLLER MODEL SI 500 by I.C Medical, Inc. — Product Code BTA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 1996
Date Received
February 2, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Portable, Aspiration (Manual Or Powered)
Device Class
Class II
Regulation Number
878.4780
Review Panel
SU
Submission Type

Other clearances by I.C Medical, Inc.

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  • K961616 — TELESCOPING PENEVAC (MODIFICATION) (May 28, 1996)
  • K955166 — PENEVAC SI. (April 11, 1996)
  • K955020 — PENEVAC ABC HANDPIECE (April 9, 1996)
  • K953418 — ELECTROCAUTERY SHROUD (October 7, 1995)
  • K954088 — TELESCOPING PENEVAC (September 22, 1995)
  • K932230 — CRYSTAL VISION AND ACCESSORIES (February 18, 1994)
  • K930097 — ELECTROCAUTERY SHROUD (July 28, 1993)

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