FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MOUTH WASH TRAY
K Number: K770120
·
Decision Jan 28, 1977
Classifications
1
FEI Numbers
219
Registration Numbers
219
Same Product Code
4
Applicant Total
24
Review Days
7
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Basic Information
- Device Name
- MOUTH WASH TRAY
- K Number
- K770120
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6230
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Pharmaseal Div., Baxter Healthcare Corp.
- Date Received
- January 21, 1977
- Decision Date
- January 28, 1977
- Product Code
- FMA
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FMA | Depressor, Tongue, Non-Surgical | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FMA), ordered by most recent decision date.
AROMATIC AND FLAVORED TONGUE DEPRESSOR
FDA 510(k)
FDA Class 1
·General Hospital
TONGUE DEPRESSOR
FDA 510(k)
FDA Class 1
·General Hospital
MINI LANCET-BLOOD LANCET
FDA 510(k)
FDA Class 1
·General Hospital
BITE STICK
FDA 510(k)
FDA Class 1
·General Hospital
Other Clearances by Pharmaseal Div., Baxter Healthcare Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K792369 | HYPERALIMENTATION DRESSING TRAY | Dec 10, 1979 | Substantially Equivalent |
| K792141 | CONTINUOUS FLUSH DEVICE | Dec 5, 1979 | Substantially Equivalent |
| K792019 | PHADECODE XA INHIBITOR ASSAY | Nov 5, 1979 | Substantially Equivalent |
| K791773 | VENTILATOR TUBE WITH FILTER | Oct 22, 1979 | Substantially Equivalent |
| K791156 | AMIPAQUE MYELOGRAM TRAY | Jul 30, 1979 | Substantially Equivalent |
| K790896 | TWO-WAY ANESTHESIA FILTER | Jun 5, 1979 | Substantially Equivalent |
| K790409 | LOW DEAD SPACE INSULIN SYRINGE | Apr 24, 1979 | Substantially Equivalent |
| K782069 | TRAY, AUXILLARY BLOCK | Jan 4, 1979 | Substantially Equivalent |
| K781797 | PREP TRAY, PREOPERATIVE SKIN | Nov 8, 1978 | Substantially Equivalent |
| K781680 | MONITORING, PRESSURE KIT | Oct 6, 1978 | Substantially Equivalent |