FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MICROTEK IRRIGATION SYSTEM
K Number: K844061
·
Decision May 21, 1985
Classifications
1
FEI Numbers
243
Registration Numbers
243
Same Product Code
76
Applicant Total
24
Review Days
215
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Basic Information
- Device Name
- MICROTEK IRRIGATION SYSTEM
- K Number
- K844061
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Microtek Medical, Inc.
- Date Received
- October 18, 1984
- Decision Date
- May 21, 1985
- 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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| K060200 | MICROTEK MEDICAL WARMING DRAPE | May 31, 2006 | Substantially Equivalent |
| K050322 | MICROTEK EQUIPMENT DRAPES | May 17, 2005 | Substantially Equivalent |
| K022903 | CHILLBUSTER | Nov 27, 2002 | Substantially Equivalent |
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| K001802 | VENODYNE DVT ADVANTAGE MODEL 610 | Jan 9, 2001 | Substantially Equivalent |
| K950906 | LESINSKI SURGICAL EAR DRESSING | Jun 22, 1995 | Substantially Equivalent |