FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELECTROMEDICS TISSUE TRAP/ #TT280
K Number: K925412
·
Decision Feb 5, 1993
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
8
Applicant Total
41
Review Days
102
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Basic Information
- Device Name
- ELECTROMEDICS TISSUE TRAP/ #TT280
- K Number
- K925412
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Electromedics, Inc.
- Date Received
- October 26, 1992
- Decision Date
- February 5, 1993
- Product Code
- BYZ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| BYZ | Trap, Sterile Specimen | FDA class 2 | General Hospital |
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