FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SURETIP SYRINGE TIP COVER
K Number: K931772
·
Decision Mar 7, 1994
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
11
Applicant Total
2
Review Days
332
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Basic Information
- Device Name
- SURETIP SYRINGE TIP COVER
- K Number
- K931772
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Western M/D, Inc.
- Date Received
- April 9, 1993
- Decision Date
- March 7, 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 |
Similar 510(k) Clearances
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POSTERIOR NASAL EPISTAXIS INSTRUMENTS
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Other Clearances by Western M/D, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K911214 | NUTIP (TM) SYRINGE SHIELD | Jul 17, 1991 | Substantially Equivalent |