FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
UNI-SYRINGE, UNI-TIP AND ACCESS SYRINGE TIPS
K Number: K942519
·
Decision Aug 23, 1994
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
11
Applicant Total
3
Review Days
89
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Basic Information
- Device Name
- UNI-SYRINGE, UNI-TIP AND ACCESS SYRINGE TIPS
- K Number
- K942519
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Bull Frog Mfg. Co.
- Date Received
- May 26, 1994
- Decision Date
- August 23, 1994
- 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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