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510(k) K820527

ANESTHESIA EXTENSION TUBES by David Simmonds Co., Inc. — Product Code FPK

K820527 is an FDA 510(k) premarket notification submitted by David Simmonds Co., Inc. for the device "ANESTHESIA EXTENSION TUBES". The FDA issued a decision of Substantially Equivalent on March 18, 1982. The device falls under product code FPK (Tubing, Fluid Delivery), a Class II device regulated under 21 CFR 880.5440. David Simmonds Co., Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 1982
Date Received
March 1, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubing, Fluid Delivery
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by David Simmonds Co., Inc.

  • K822848 — PRIMARY & SECONDARY I.V. TUBING SETS (October 15, 1982)
  • K820574 — ARMBOARD FOR INTRAVENOUS ANES. IN DENTAL (March 23, 1982)

Other clearances for product code FPK

  • K131517 — MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING (August 2, 2013)
  • K063114 — DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES (February 9, 2007)
  • K063239 — LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, (December 11, 2006)
  • K052431 — MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801 (November 29, 2005)
  • K041178 — EMPOWER TRANSFER SET, (CAT. NO. 7725) (July 16, 2004)
  • K031808 — MEDRAD SWABBABLE VALVE TRANSFER SET (July 11, 2003)
  • K022431 — MEDRAD TRANSFER SET (September 5, 2002)
  • K965208 — POLYFIN EXTENSION SET, MODELS 126 AND 128 (February 26, 1997)
  • K953864 — SILCLEAR TUBING (MODIFICATION) (November 6, 1995)
  • K950508 — SYSMEX SF-3000 (November 3, 1995)

FDA data resources