FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEALTHPAK X-RAY SOX BARRIERS
K Number: K923307
·
Decision Jan 21, 1993
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
41
Applicant Total
4
Review Days
258
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Basic Information
- Device Name
- HEALTHPAK X-RAY SOX BARRIERS
- K Number
- K923307
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1810
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Healthpak, Inc.
- Date Received
- May 8, 1992
- Decision Date
- January 21, 1993
- Product Code
- EAP
- Advisory Committee
- Dental
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| EAP | Unit, X-Ray, Intraoral | FDA class 2 | Dental |
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