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510(k) K781700

IONOTPHORETIC APPLICATOR by Mcghan Medical Corp. — Product Code KTB

K781700 is an FDA 510(k) premarket notification submitted by Mcghan Medical Corp. for the device "IONOTPHORETIC APPLICATOR". The FDA issued a decision of Substantially Equivalent on November 3, 1978. The device falls under product code KTB (Device, Iontophoresis, Specific Uses), a Class II device regulated under 21 CFR 890.5525. Mcghan Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 1978
Date Received
October 10, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Iontophoresis, Specific Uses
Device Class
Class II
Regulation Number
890.5525
Review Panel
PM
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)
  • K781087 — MEDICAL GRADE SILICONE ELASTOMER TUBING (November 22, 1978)

Other clearances for product code KTB

  • K180627 — Macroduct Advanced Model 3710 (July 27, 2018)
  • K033192 — RH-950 (December 22, 2003)
  • K031551 — NORTHSTAR LIDOCAINE IONTOPHORETIC CONTROLLER (NORTHSTAR CONTROLLER-D) (August 20, 2003)
  • K031115 — RH-900 (July 10, 2003)
  • K010031 — NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM (March 20, 2001)
  • K001522 — TRANSQ3 (October 18, 2000)
  • K001410 — PHORESOR MODEL PM2000 (August 1, 2000)
  • K992874 — Q-SWEAT QUANTITATIVE SWEAT MEASUREMENT SYSTEM (November 18, 1999)
  • K974855 — PHORESOR II, MODEL PM900 (March 27, 1998)
  • K954126 — TRANSQ ELECTRODE PHORESOR II (January 19, 1996)

FDA data resources