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510(k) K894369

APDYNE PHENOL APPLICATOR KIT by Apdyne Medical Co. — Product Code KCJ

Clearance Details

Decision
SESD (Substantially Equivalent (with conditions))
Decision Date
October 12, 1989
Date Received
July 14, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Applicator, Ent
Device Class
Class I
Regulation Number
874.5220
Review Panel
EN
Submission Type

Other clearances by Apdyne Medical Co.

  • K911080 — HYGIENA-TRACH (May 20, 1991)

Other clearances for product code KCJ

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  • K921053 — LAPAROMED LIGATING LOOP (August 6, 1992)
  • K832667 — LUCAE'S EAR & NASAL APPLICATORS (September 29, 1983)