FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ORAL PHARYNGEAL CLEANSING DEVICE
K Number: K905011
·
Decision Jan 31, 1991
Classifications
1
FEI Numbers
111
Registration Numbers
111
Same Product Code
283
Applicant Total
23
Review Days
85
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Basic Information
- Device Name
- ORAL PHARYNGEAL CLEANSING DEVICE
- K Number
- K905011
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Concord/Portex
- Date Received
- November 7, 1990
- Decision Date
- January 31, 1991
- Product Code
- EIA
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| EIA | Unit, Operative Dental | FDA class 1 | Dental |
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Other Clearances by Concord/Portex
| K Number | Device Name | ||
|---|---|---|---|
| K923559 | STERI-CATH MDI | Oct 25, 1993 | Substantially Equivalent |
| K930218 | SUBCUTANEOUS TUNNELING NEEDLE AND HANDLES | Jul 27, 1993 | Substantially Equivalent |
| K924541 | EPIDURAL MINIPACK | Jul 9, 1993 | Unknown |
| K930286 | DRI-VENDT/PROVENT/ACCUVENT ARTERIAL BLOOD GAS KITS | Jun 22, 1993 | Unknown |
| K923127 | NEEDLE-PRO CARTRIDGE | Apr 29, 1993 | Substantially Equivalent |
| K923910 | HEAT MOISTURE CONDENSER | Jan 26, 1993 | Substantially Equivalent |
| K922749 | LOW PROFILE TRACHEOSTOMY TUBE | Sep 2, 1992 | Substantially Equivalent |
| K922445 | VACU-PRO | Aug 12, 1992 | Substantially Equivalent |
| K915452 | ANESTHESIA BREATHING CIRCUIT | Feb 14, 1992 | Substantially Equivalent |
| K911809 | NEW-VENT | Aug 26, 1991 | Substantially Equivalent |