FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GERITREX STERILE WATER FOR IRRIGATION
K Number: K931511
·
Decision Feb 14, 1994
Classifications
1
FEI Numbers
331
Registration Numbers
331
Same Product Code
83
Applicant Total
4
Review Days
325
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Basic Information
- Device Name
- GERITREX STERILE WATER FOR IRRIGATION
- K Number
- K931511
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Geritrex Corp.
- Date Received
- March 26, 1993
- Decision Date
- February 14, 1994
- Product Code
- JOL
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| JOL | Catheter And Tip, Suction | FDA class 2 | General Hospital |
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