510(k) K890501

SECOND ASSISTANT by 3M Company — Product Code FWZ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 10, 1989
Date Received: February 1, 1989
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Operating Room Accessories Table Tray
Device Class: Class I
Regulation Number: 878.4950
Review Panel: SU
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.

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K241710 — 3M Attest Super Rapid Readout Biological Indicator 1492V; 3M Attest Auto-rea (September 12, 2024)
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Other clearances for product code FWZ

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K945415 — 'LIL MAC ACCESSORY CLAMP(TM) (November 22, 1994)
K944779 — CARBON LIGHTS HAND SURGERY TABLE (October 14, 1994)
K935381 — KAPS POSITIONING ARM (April 15, 1994)
K931037 — WHITMORE VACUUM-LOCK SPINAL FRAME (VLSF-100) (July 30, 1993)
K926225 — SPONGE COUNTER (March 5, 1993)
K925035 — MIDKIFF GEOSTATIC CLAMP (February 18, 1993)
K905565 — LATERAL BUTTRESS SUPPORT (February 21, 1991)
K905564 — PREP AND OPERATING STAND (February 21, 1991)
K910031 — PARK CITY SHOULDER POSITIONER (January 24, 1991)