MONTGOMERY RADIOPAQUE SALIVARY BYPASS TUBE
FDA 510(k) clearance K962688 · decided 1996-07-25
Clearance details
- K-number
- K962688
- Device name
- MONTGOMERY RADIOPAQUE SALIVARY BYPASS TUBE
- Applicant
- Boston Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-07-11
- Decision date
- 1996-07-25
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- KCF
- Device class
- 1
- Regulation number
- 874.4420
- 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 |
|---|---|---|
| PHARYNGEAL SALIVARY BYPASS TUBE (K923355) | Boston Medical Products, Inc. | 1992-10-06 |
| MONTG. ESOPHAGEAL -SALIVARY BYPASS- TUBE (K812305) | Boston Medical Products, Inc. | 1981-09-08 |
Recalls involving this device
No recalls on record reference this clearance.