FDA 510(k)
FDA class 1
Substantially Equivalent
🇹🇭 Thailand
PATIENT EXAMINATION GLOVES (LATEX)
K Number: K892791
·
Decision Aug 24, 1989
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
1
Applicant Total
3
Review Days
135
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Basic Information
- Device Name
- PATIENT EXAMINATION GLOVES (LATEX)
- K Number
- K892791
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3920
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Union Industrial Co., Ltd.
- Date Received
- April 11, 1989
- Decision Date
- August 24, 1989
- Product Code
- IMM
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| IMM | Footrest, Wheelchair | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
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