FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PEDO JACKETS OR PJ'S
K Number: K931352
·
Decision Jul 21, 1993
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
8
Applicant Total
3
Review Days
126
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Basic Information
- Device Name
- PEDO JACKETS OR PJ'S
- K Number
- K931352
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3330
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- George M. Wilson, Dds
- Date Received
- March 17, 1993
- Decision Date
- July 21, 1993
- Product Code
- ELZ
- 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 |
|---|---|---|---|
| ELZ | Crown, Preformed | FDA class 1 | Dental |
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