FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LACTOSORB RAPIDFLAP
K Number: K003281
·
Decision Aug 7, 2001
Classifications
1
FEI Numbers
110
Registration Numbers
110
Same Product Code
288
Applicant Total
404
Review Days
292
Basic Information
- Device Name
- LACTOSORB RAPIDFLAP
- K Number
- K003281
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4760
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BIOMET, INC.
- Date Received
- October 19, 2000
- Decision Date
- August 7, 2001
- Product Code
- JEY
- 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 |
|---|---|---|---|
| JEY | Plate, Bone | FDA class 2 | Dental |
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