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510(k) K950743

ORAL PROCEDURE PACK by Transidyne General Corp. — Product Code EGS

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
March 31, 1995
Date Received
February 17, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Contra- And Right-Angle Attachment, Dental
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

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  • K950403 — SURGICAL SAW BLADES (February 21, 1995)
  • K924811 — I.V. START KIT (June 17, 1993)
  • K924243 — TRACHEOSTOMY CARE KIT (June 16, 1993)
  • K922339 — SUTURE REMOVAL KIT (December 11, 1992)
  • K922041 — PRIMARY SURGICAL DRESSING TRAY (November 6, 1992)
  • K897133 — MODEL 1050 - UMBILICAL CORD BLOOD SAMPLING KIT (March 30, 1990)

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