510(k) K091135
- Device
- RUTTER SUPRA STOMAL STENTS
- Applicant
- BOSTON MEDICAL PRODUCTS, INC.
- 510(k) number
- K091135
- Product code
- FWN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-09-14
- Date received
- 2009-04-20
- Regulation
- 874.3620
- Classification name
- Prosthesis, Larynx (stents And Keels)
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- MICHAEL A WARREN
- Address
- 117 Flanders Rd. Westborough MA US 01581 01581
FDA Registration Numbers#
- 1032347
- 1220850
- 1219795
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FWN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K000154 | ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1 | E. Benson Hood Lab, Inc. | 2000-03-29 |
| K962693 | MONTGOMERY RADIOPAQUE LARYNGEAL KEEL | Boston Medical Products, Inc. | 1996-08-09 |
| K896667 | LORENZ STENT | Walter Lorenz Surgical, Inc. | 1990-02-22 |
| K884810 | SILICONE LARYNGEAL STENT | Hood Laboratories | 1989-05-10 |
| K864936 | 'EXMOOR' DAS GUPTA LARYNGEAL KEEL | Exmoor Plastics , Ltd. | 1987-04-27 |
| K853726 | LARYNGEAL | Hood Laboratories | 1986-03-12 |
| K842800 | MONTG. LARYNGEAL KEEL | Boston Medical Products, Inc. | 1984-08-02 |
| K842287 | MONTGOMERY LARYNGEAL STENT | Boston Medical Products, Inc. | 1984-06-27 |
| K841347 | LARYNGEAL STENT | E. Benson Hood Laboratories, Inc. | 1984-05-02 |
Legacy Summary#
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FDA Review#
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