510(k) K945671

CONTINUOUS EPIDURAL ANESTHESIA TRAY by Trinity Laboratories, Inc. — Product Code CAZ

Clearance Details

Decision: SESK (Substantially Equivalent (kit))
Decision Date: February 16, 1995
Date Received: November 18, 1994
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 Trinity Laboratories, Inc.

K981441 — HEART CATH TRAY, STERILE, DISPOSABLE (July 10, 1998)
K974238 — DENTAL TRAY, STERILE, DISPOSABLE (February 4, 1998)
K974286 — CIRCUMCISION TRAY, CAT. NO. 70340 (December 12, 1997)
K972160 — CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATIO (August 1, 1997)
K970722 — EYE TRAY (March 31, 1997)
K965201 — O.R. SCRUB PREP TRAY, STERILE, DISPOSABLE (February 14, 1997)
K964921 — BASIC BIOPSY TRAY. DISPOSABLE, STERILE (January 22, 1997)
K953929 — MID-STREAM COLLECTION SET-STERILE (November 16, 1995)
K952058 — STERILE V.A.D. (VASCULAR ACCESS DEVICES) ACCESS KIT, DISPOSABLE (September 21, 1995)
K953070 — WOUNDFOAM 4 X 4 (September 8, 1995)

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