FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MODEL OPO-32 IRRIGATION SLEEVE
K Number: K874543
·
Decision Jan 14, 1988
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
3
Applicant Total
33
Review Days
72
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Basic Information
- Device Name
- MODEL OPO-32 IRRIGATION SLEEVE
- K Number
- K874543
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Allergan, Inc.
- Date Received
- November 3, 1987
- Decision Date
- January 14, 1988
- Product Code
- EIB
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| EIB | Syringe, Irrigating (Dental) | FDA class 1 | Dental |
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