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510(k) K832967

DUCKBILL VOICE PROSTHESIS & TRACHEO by American V. Mueller — Product Code EWL

K832967 is an FDA 510(k) premarket notification submitted by American V. Mueller for the device "DUCKBILL VOICE PROSTHESIS & TRACHEO". The FDA issued a decision of Substantially Equivalent on December 23, 1983. The device falls under product code EWL (Prosthesis, Laryngeal (Taub)), a Class II device regulated under 21 CFR 874.3730. American V. Mueller has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 1983
Date Received
September 1, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Laryngeal (Taub)
Device Class
Class II
Regulation Number
874.3730
Review Panel
EN
Submission Type

Other clearances by American V. Mueller

  • K873771 — HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO (December 18, 1987)
  • K873332 — MAXIVAC(TM) CLOSED WOUND SUCTION DRAINAGE SYSTEM (September 8, 1987)
  • K871685 — HEYER-SCHULTE SPETZLER LUMBAR-PERITONEAL SHUNT SYS (June 12, 1987)
  • K864676 — HEYER-SCHULTE HERMETIC EXTERNAL CSF DRAIN. SYSTEM (December 29, 1986)
  • K862772 — V. MUELLER (R) GOOSENECK CIRCULAR STAPLER (August 18, 1986)
  • K861471 — V. MUELLER VITAL CLIP-HEMOSTATIC CLIP (June 6, 1986)
  • K854568 — V. MUELLER PNEUMO-INTESTINAL 15 VASCULAR & 30 STAP (December 2, 1985)
  • K854049 — HEYER-SCHULTE SYRINGO PERITONEAL SHUNT (November 27, 1985)
  • K851082 — V. MUELLER BLOM-SINGER ESOPHAGEAL INSUFFLATION TES (July 22, 1985)
  • K851974 — V. MUELLER VITAL SKIN STAPLER (June 11, 1985)

Other clearances for product code EWL

  • K240763 — FirstFit Surgical Kit (December 18, 2024)
  • K141380 — PROVOX FREEHANDS FLEXIVOICE (September 26, 2014)
  • K131947 — PROVOX VEGA PUNCTURE SET (October 18, 2013)
  • K092593 — PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM) (October 14, 2010)
  • K093258 — BLOM-SINGER INDWELLING TEP OCCLUDER (March 3, 2010)
  • K090455 — PROVOX VEGA, MODEL 8130-8135 (June 5, 2009)
  • K082206 — BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-20 (September 4, 2008)
  • K043138 — PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134 (November 22, 2004)
  • K022125 — PROVOX FREEHANDS HME, MODEL 7710 (July 30, 2002)
  • K991587 — BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS (June 25, 1999)

FDA data resources