FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HEALTHPAK CHAIR SOX BARRIERS
K Number: K922175
·
Decision Aug 6, 1992
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
62
Applicant Total
4
Review Days
90
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Basic Information
- Device Name
- HEALTHPAK CHAIR SOX BARRIERS
- K Number
- K922175
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6250
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Healthpak, Inc.
- Date Received
- May 8, 1992
- Decision Date
- August 6, 1992
- Product Code
- KLC
- 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 |
|---|---|---|---|
| KLC | Chair, Dental, With Operative Unit | FDA class 1 | Dental |
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