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510(k) K853014

MCGHAN TISSUE EXPANDER FILL KIT by Mcghan Medical Corp. — Product Code LCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 1985
Date Received
July 17, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tissue Expander And Accessories
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Mcghan Medical Corp.

  • K873476 — MINI-MOTOR HAND ENGINE & ACCESS. DERMABRASION BURS (September 11, 1987)
  • K873475 — MICRO-TORQUE HAND ENGINE & ACCESS. DERMABRA. 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)
  • K843704 — MCGHAN TISSUE EXPANDER (October 31, 1984)
  • K781087 — MEDICAL GRADE SILICONE ELASTOMER TUBING (November 22, 1978)
  • K781700 — IONOTPHORETIC APPLICATOR (November 3, 1978)

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