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510(k) K932120

BLOM-SINGER INDWELLING LOW PRESSURE VOICE PROSTHES by Helix Medical, Inc. — Product Code EWL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 1994
Date Received
May 3, 1993
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 Helix Medical, Inc.

  • K130736 — BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS (December 17, 2013)
  • K131745 — BLOM-SINGER SEPTAL PERFORATION PROSTHESIS (September 17, 2013)
  • K093258 — BLOM-SINGER INDWELLING TEP OCCLUDER (March 3, 2010)
  • K082206 — BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-20 (September 4, 2008)
  • K023259 — INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200 (December 26, 2002)
  • K991587 — BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS (June 25, 1999)
  • K945287 — INHEALTH BLOM-SINGER INDWELLING VALVED INSERT ACCESSORY DEVICE (December 9, 1994)
  • K945288 — INHEALTH BLOM-SINGER INDWELLING PLUG INSERT ACCESSORY DEVICE (December 2, 1994)
  • K932163 — BLOM-SINGER VOICE PROSTHESIS FLUSHING PIPET (December 15, 1993)
  • K930105 — BLOM-SINGER LOW PRESSURE VOICE PROSTHESIS,P.I.D.S. (May 17, 1993)

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  • 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)