FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SOFT-WEAR HEADGEAR AND SAFETY MODULES
K Number: K932761
·
Decision Oct 7, 1993
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
35
Applicant Total
3
Review Days
121
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Basic Information
- Device Name
- SOFT-WEAR HEADGEAR AND SAFETY MODULES
- K Number
- K932761
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.5500
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Professional Positioners, Inc.
- Date Received
- June 8, 1993
- Decision Date
- October 7, 1993
- Product Code
- DZB
- 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 |
|---|---|---|---|
| DZB | Headgear, Extraoral, Orthodontic | FDA class 2 | Dental |
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