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510(k) K800877

ANESTHESIA EXTENSION TUBES by Harvard Laboratories — Product Code FPK

K800877 is an FDA 510(k) premarket notification submitted by Harvard Laboratories for the device "ANESTHESIA EXTENSION TUBES". The FDA issued a decision of Substantially Equivalent on June 17, 1980. The device falls under product code FPK (Tubing, Fluid Delivery), a Class II device regulated under 21 CFR 880.5440. Harvard Laboratories has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 1980
Date Received
April 17, 1980
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 Harvard Laboratories

  • K822765 — SIGMOIDOSCOPE, FLEXIBLE (November 17, 1982)
  • K810573 — TUBE FEEDING SET (April 23, 1981)
  • K810574 — SUCTION COLLECTION BOTTLE, DISPOSABLE (April 21, 1981)
  • K800878 — SECONDARY I.V. TUBING SETS (June 17, 1980)
  • K800879 — CLEAR PLASTIC CONNECTING TUBES (June 17, 1980)
  • K800880 — PLASTIC TUBING ADAPTERS 5-IN-1- (May 14, 1980)
  • K800881 — DISPOSABLE BERMAN AIRWAYS (May 8, 1980)

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