MONTG. LARYNGEAL KEEL
FDA 510(k) clearance K842800 · decided 1984-08-02
Clearance details
- K-number
- K842800
- Device name
- MONTG. LARYNGEAL KEEL
- Applicant
- Boston Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-07-17
- Decision date
- 1984-08-02
- Days to decision
- 16 days
- Clearance type
- Traditional
- Product code
- FWN
- Device class
- 2
- Regulation number
- 874.3620
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Westborough, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| RUTTER SUPRA STOMAL STENTS (K091135) | Boston Medical Products, Inc. | 2009-09-14 |
| ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1 (K000154) | E. Benson Hood Lab, Inc. | 2000-03-29 |
| MONTGOMERY RADIOPAQUE LARYNGEAL KEEL (K962693) | Boston Medical Products, Inc. | 1996-08-09 |
| LORENZ STENT (K896667) | Walter Lorenz Surgical, Inc. | 1990-02-22 |
| SILICONE LARYNGEAL STENT (K884810) | Hood Laboratories | 1989-05-10 |
| 'EXMOOR' DAS GUPTA LARYNGEAL KEEL (K864936) | Exmoor Plastics , Ltd. | 1987-04-27 |
| LARYNGEAL (K853726) | Hood Laboratories | 1986-03-12 |
| MONTGOMERY LARYNGEAL STENT (K842287) | Boston Medical Products, Inc. | 1984-06-27 |
| LARYNGEAL STENT (K841347) | E. Benson Hood Laboratories, Inc. | 1984-05-02 |
Recalls involving this device
No recalls on record reference this clearance.