FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MPI MON-IT II, SMART SAFETY SYSTEM
K Number: K821169
·
Decision Aug 6, 1982
Classifications
1
FEI Numbers
839
Registration Numbers
839
Same Product Code
2251
Applicant Total
7
Review Days
102
Basic Information
- Device Name
- MPI MON-IT II, SMART SAFETY SYSTEM
- K Number
- K821169
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- MEDICAL PLASTICS, INC.
- Date Received
- April 26, 1982
- Decision Date
- August 6, 1982
- 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 MEDICAL PLASTICS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K902384 | ABDOMINAL OR C-SECTION DRAPE SHEET | Aug 9, 1990 | Substantially Equivalent |
| K896088 | FEMORAL ANGIOGRAPHY DRAPE | Nov 17, 1989 | Substantially Equivalent |
| K895404 | UNDER BUTTOCKS DRAPE | Oct 6, 1989 | Substantially Equivalent |
| K890101 | FEMORAL ANGIOGRAPHY DRAPE | Mar 16, 1989 | Substantially Equivalent |
| K822072 | MPI ELECTROSURGICAL CAPACTIVE DISPER | Aug 19, 1982 | Substantially Equivalent |
| K781148 | ELECTROSURGICAL PENCIL SYSTEM | Aug 31, 1978 | Substantially Equivalent |