FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
NEUTRALECT ADULT STANDARD, RETURN (REM) & PAEDIATRIC ELECTROSURGERY PLATE (MODIFICATION)
K Number: K955261
·
Decision Jan 30, 1996
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
7
Review Days
82
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Basic Information
- Device Name
- NEUTRALECT ADULT STANDARD, RETURN (REM) & PAEDIATRIC ELECTROSURGERY PLATE (MODIFICATION)
- K Number
- K955261
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Msb , Ltd.
- Date Received
- November 9, 1995
- Decision Date
- January 30, 1996
- Product Code
- GEI
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Msb , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K980229 | MSB TENS ELECTRODES (DISPOSABLE) | Feb 27, 1998 | Substantially Equivalent |
| K944497 | UNILECT, MONITAB AND BIOTRACE-HR | May 17, 1996 | Substantially Equivalent |
| K944496 | BIOTRACE-N, NS, 410 AND RT | May 16, 1996 | Substantially Equivalent |
| K950587 | ECOTABS | Oct 16, 1995 | Substantially Equivalent |
| K944260 | ECG ELECTRODE | Jul 7, 1995 | Substantially Equivalent |
| K944817 | NEUTRALECT ADULT STANDARD, RETURN (REM), PAEDIATRIC STANDARD, RETURN (REM) | Nov 9, 1994 | Substantially Equivalent |