FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INTROCULAR FLUID INJECTOR
K Number: K881707
·
Decision Oct 21, 1988
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
4
Applicant Total
5
Review Days
193
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Basic Information
- Device Name
- INTROCULAR FLUID INJECTOR
- K Number
- K881707
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- B&B Medical Assoc., Inc.
- Date Received
- April 11, 1988
- Decision Date
- October 21, 1988
- Product Code
- FIH
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FIH | Pump, Infusion Or Syringe, Extra-Luminal | FDA class 2 | Gastroenterology, Urology |
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