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510(k) K860030

SURGIDYNE VARIDYNE, MODEL 140-2I & MODEL 140-2ID by Surgidyne, Inc. — Product Code BTA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1986
Date Received
January 6, 1986
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 Surgidyne, Inc.

  • K892334 — LEONARD TUBE (May 31, 1989)
  • K883582 — VARIDYNE MODEL 250 SUCTION DRAINAGE SYSTEM (October 3, 1988)
  • K864822 — VARIDYNE 550, MODELS 12E,12M,24E & 24M SUCTION SYS (January 15, 1987)
  • K852180 — SURGIDYNES VARIDYNE 350-2I & 350-2C CORDLESS ELEC. (July 1, 1985)
  • K850634 — SURGIDYNE SURGIFLO C.W.S. DRAIN PRODUCTS (June 28, 1985)

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