510(k) K971062

OPPORTUNITY INC. GENERAL PURPOSE TRAY by Opportunity, Inc. — Product Code LRO

Clearance Details

Decision: SN ()
Decision Date: June 9, 1997
Date Received: March 24, 1997
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: General Surgery Tray
Device Class: Class II
Regulation Number: 878.4370
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

Other clearances by Opportunity, Inc.

K971093 — OPPORTUNITY I.V. START KIT (September 16, 1997)
K971090 — OPPORTUNITY DRESSING CHANGE TRAY (September 16, 1997)
K971089 — OPPORTUNITY, INC. LACERATION TRAY (September 16, 1997)
K971088 — OPPORTUNITY INCISION AND DRAINAGE TRAY (September 16, 1997)
K971091 — OPPURTUNITY TRACHEOSTOMY CARE KIT (September 16, 1997)
K971095 — OPPORTUNITY SUTURE REMOVAL KIT (September 16, 1997)
K971061 — OPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAY (June 11, 1997)

Other clearances for product code LRO

K213481 — Medline General Surgery Tray (May 24, 2022)
K212258 — Medline Cardiovascular Procedure Kit (December 3, 2021)
K041080 — SURGICAL DRAPE KIT - D.I.R.R.A. SRL (November 30, 2004)
K030721 — QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE (March 31, 2003)
K023276 — AMSINO TRACHEOSTOMY CARE TRAY (December 9, 2002)
K980137 — WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY PROCEDURE TRAY (January 30, 1998)
K971061 — OPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAY (June 11, 1997)
K932221 — NEUROLOGICAL OR CRANI TRAYS (PACKS) (March 19, 1997)
K970286 — PRESBYTERIAN LINEN SERVICES SURGICAL PACKS (March 10, 1997)
K970187 — RUNYON LARGE VOLUME PARACENTESIS KIT (February 14, 1997)