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510(k) K781087

MEDICAL GRADE SILICONE ELASTOMER TUBING by Mcghan Medical Corp. — Product Code FPK

K781087 is an FDA 510(k) premarket notification submitted by Mcghan Medical Corp. for the device "MEDICAL GRADE SILICONE ELASTOMER TUBING". The FDA issued a decision of Substantially Equivalent on November 22, 1978. The device falls under product code FPK (Tubing, Fluid Delivery), a Class II device regulated under 21 CFR 880.5440. Mcghan Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 1978
Date Received
June 29, 1978
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 Mcghan Medical Corp.

  • K873475 — MICRO-TORQUE HAND ENGINE & ACCESS. DERMABRA. BURS (September 11, 1987)
  • K873476 — MINI-MOTOR HAND ENGINE & ACCESS. DERMABRASION BURS (September 11, 1987)
  • K870754 — MCGHAN TISSUE EXPANDER FILL SYSTEM (March 31, 1987)
  • K864185 — MCGHAN LONGTERM MAMMARY EXPANDER, RTV DESIGN (December 24, 1986)
  • K864184 — MCGHAN LONGTERM MAMMARY EXPANDER/GEL-SALINE DESIGN (December 24, 1986)
  • K862203 — MCGHAN MAGNA-SITE(TM) TISSUE EXPANDER (July 23, 1986)
  • K854794 — MCGHAN INTEGRAL VALVE TISSUE EXPANDER (December 24, 1985)
  • K853014 — MCGHAN TISSUE EXPANDER FILL KIT (September 18, 1985)
  • K843704 — MCGHAN TISSUE EXPANDER (October 31, 1984)
  • K781700 — IONOTPHORETIC APPLICATOR (November 3, 1978)

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