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510(k) K781491

PRO-MOLD, CUSTOM EAR by Mcghan Medical Corp. — Product Code EWD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1978
Date Received
August 28, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Protector, Hearing (Insert)
Device Class
Class U
Regulation Number
Review Panel
EN
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)
  • K864184 — MCGHAN LONGTERM MAMMARY EXPANDER/GEL-SALINE DESIGN (December 24, 1986)
  • K864185 — MCGHAN LONGTERM MAMMARY EXPANDER, RTV 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 EWD

  • K020296 — ADULT SILICONE EAR PLUGS, MODELS # 68053, 68057 (June 25, 2002)
  • K972923 — SUPER SILIPLUGS EAR PLUGS (October 27, 1997)
  • K971517 — SILICONE PUTTY EAR PLUGS (June 2, 1997)
  • K962292 — HEARSAVER (October 29, 1996)
  • K960500 — THE VIRTUAL M-332 (April 3, 1996)
  • K945376 — DOC'S PROPLUGS EAR PLUGS (November 14, 1995)
  • K930203 — MODEL 322 CLINICAL AUDIOMETER (July 8, 1993)
  • K915739 — #903 SILAFLEX II (June 30, 1992)
  • K910177 — SEAL-RITE SILICONE EAR PLUG (June 24, 1991)
  • K862045 — DOC'S PROPLUGS EAR PLUGS (April 10, 1987)