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510(k) K874674

AIK-100 ANESTHESIA INDUCTION KIT/TRAY by Medical Repackers Co. — Product Code CAZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 1988
Date Received
November 13, 1987
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 Medical Repackers Co.

  • K890575 — ACCUTHERM PTS-200 (May 5, 1989)
  • K882977 — ASK-300 (January 5, 1989)
  • K881313 — IQK-200 (May 19, 1988)
  • K881429 — YANKAUER SUCTION INSTRU./LAYTEX GLOVES/SUCT. CATH. (April 25, 1988)

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