FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NUMOBAG
K Number: K981949
·
Decision Feb 3, 1999
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
22
Applicant Total
2
Review Days
245
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Basic Information
- Device Name
- NUMOBAG
- K Number
- K981949
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5650
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Numotech, Inc.
- Date Received
- June 3, 1998
- Decision Date
- February 3, 1999
- Product Code
- KPJ
- 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 |
|---|---|---|---|
| KPJ | Chamber, Oxygen, Topical, Extremity | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Numotech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K943433 | TOTAL CONTACT SEAT RIPPLE SYSTEM | Jul 31, 1995 | Substantially Equivalent |