510(k) K974132
- Device
- VOICE MASTER PROSTHESIS
- Applicant
- E. BENSON HOOD LAB, INC.
- 510(k) number
- K974132
- Product code
- EWL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-02-25
- Date received
- 1997-11-03
- Regulation
- 874.3730
- Classification name
- Prosthesis, Laryngeal (taub)
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ANTHONY M SACCHETTI
- Address
- 575 Washington St. Pembroke MA US 02359 02359
FDA Registration Numbers#
- 8032044
- 3013188547
- 2025182
- 2029275
- 2011171
Source Documents#
Other 510(k) Records For Product Code EWL #
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|---|---|---|---|
| K240763 | FirstFit Surgical Kit | Freudenberg Medical, LLC | 2024-12-18 |
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| K131947 | PROVOX VEGA PUNCTURE SET | Atos Medical AB | 2013-10-18 |
| K092593 | PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM) | Atos Medical AB | 2010-10-14 |
| K093258 | BLOM-SINGER INDWELLING TEP OCCLUDER | Helix Medical, LLC | 2010-03-03 |
| K090455 | PROVOX VEGA, MODEL 8130-8135 | Atos Medical AB | 2009-06-05 |
| K082206 | BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES | Helix Medical, LLC | 2008-09-04 |
| K043138 | PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134 | Atos Medical AB | 2004-11-22 |
| K022125 | PROVOX FREEHANDS HME, MODEL 7710 | Atos Medical AB | 2002-07-30 |
| K991587 | BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS | Helix Medical, Inc. | 1999-06-25 |
| K971244 | PROVOX 2 VOICE PROSTHESIS SYSTEM | Atos Medical AB | 1997-06-06 |
| K945287 | INHEALTH BLOM-SINGER INDWELLING VALVED INSERT ACCESSORY DEVICE | Helix Medical, Inc. | 1994-12-09 |
| K945288 | INHEALTH BLOM-SINGER INDWELLING PLUG INSERT ACCESSORY DEVICE | Helix Medical, Inc. | 1994-12-02 |
| K940638 | PROVOX(TM) VOICE PROSTHESIS | Atos Medical AB | 1994-06-22 |
| K932120 | BLOM-SINGER INDWELLING LOW PRESSURE VOICE PROSTHES | Helix Medical, Inc. | 1994-04-15 |
Legacy Summary#
summary
FDA Review#
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