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510(k) K924707

VARIOUS ANESTHETIC KITS OR TRAYS by Specialty Medical Products Co. — Product Code CAZ

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
June 17, 1993
Date Received
September 18, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anesthesia Conduction Kit
Device Class
Class II
Regulation Number
868.5140
Review Panel
AN
Submission Type

This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Other clearances by Specialty Medical Products Co.

  • K922533 — IV START KIT CUSTOM SMP # A-Z (March 23, 1993)
  • K922845 — BASIC DRESSING CHANGE TRAY SMP 102A (December 29, 1992)
  • K874596 — PERFORATED SOAKING TUBE (December 2, 1987)

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