FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PRO-TIP DISPOSABLE 3/1 SYRINGE NOZZLE
K Number: K923285
·
Decision Sep 15, 1992
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
11
Applicant Total
529
Review Days
71
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Basic Information
- Device Name
- PRO-TIP DISPOSABLE 3/1 SYRINGE NOZZLE
- K Number
- K923285
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Smith & Nephew, Inc.
- Date Received
- July 6, 1992
- Decision Date
- September 15, 1992
- Product Code
- ECB
- 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 |
|---|---|---|---|
| ECB | Unit, Syringe, Air And/Or Water | FDA class 1 | Dental |
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