FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IRRI-EVACUATOR
K Number: K895757
·
Decision Oct 19, 1989
Classifications
1
FEI Numbers
243
Registration Numbers
243
Same Product Code
76
Applicant Total
3
Review Days
23
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Basic Information
- Device Name
- IRRI-EVACUATOR
- K Number
- K895757
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Mikro-Tek Laboratories
- Date Received
- September 26, 1989
- Decision Date
- October 19, 1989
- Product Code
- GBX
- 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 |
|---|---|---|---|
| GBX | Catheter, Irrigation | FDA class 1 | General, Plastic Surgery |
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