FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PHARYNGEAL SALIVARY BYPASS TUBE
K Number: K923355
·
Decision Oct 6, 1992
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
2
Applicant Total
33
Review Days
90
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Basic Information
- Device Name
- PHARYNGEAL SALIVARY BYPASS TUBE
- K Number
- K923355
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4420
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Boston Medical Products, Inc.
- Date Received
- July 8, 1992
- Decision Date
- October 6, 1992
- Product Code
- KCF
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KCF | Dilator, Esophageal, Ent | FDA class 1 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KCF), ordered by most recent decision date.
MONTGOMERY RADIOPAQUE SALIVARY BYPASS TUBE
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
MONTG. ESOPHAGEAL -SALIVARY BYPASS- TUBE
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
Other Clearances by Boston Medical Products, Inc.
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|---|---|---|---|
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| K972459 | RHINOCELL NASAL PACKINGS | Aug 4, 1997 | Substantially Equivalent |
| K972096 | BIVALVE NASAL SPLINT | Jul 15, 1997 | Substantially Equivalent |
| K972078 | POST-STOP EPISTAXIS CATHETER | Jul 10, 1997 | Substantially Equivalent |
| K972092 | NASAL AIRWAY SPLINT | Jul 8, 1997 | Substantially Equivalent |
| K972151 | DOYLE COMBO NASAL AIRWAY SPLINT | Jul 7, 1997 | Substantially Equivalent |
| K972082 | CUSTOM NASAL SPLINT | Jul 3, 1997 | Substantially Equivalent |
| K972060 | NASAL SEPTAL BUTTON | Jul 3, 1997 | Substantially Equivalent |
| K972076 | EPI-MAX EPISTAXIS CATHETER | Jun 26, 1997 | Substantially Equivalent |