FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TAB PAK
K Number: K882731
·
Decision Dec 14, 1988
Classifications
1
FEI Numbers
123
Registration Numbers
123
Same Product Code
2
Applicant Total
2
Review Days
166
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Basic Information
- Device Name
- TAB PAK
- K Number
- K882731
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5050
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Dynex Trading Co.
- Date Received
- July 1, 1988
- Decision Date
- December 14, 1988
- Product Code
- NXB
- Advisory Committee
- Physical Medicine
- 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 |
|---|---|---|---|
| NXB | Dispenser, Solid Medication | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NXB), ordered by most recent decision date.
THE HEART PROTECTOR
FDA 510(k)
FDA Class 1
·Physical Medicine
NITROGLYCERINE CONTAINER
FDA 510(k)
FDA Class 1
·Physical Medicine
Other Clearances by Dynex Trading Co.
| K Number | Device Name | ||
|---|---|---|---|
| K885055 | INSU COOL | Apr 26, 1989 | Substantially Equivalent |