FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE
K Number: K113839
·
Decision Apr 12, 2012
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
35
Applicant Total
53
Review Days
106
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Basic Information
- Device Name
- RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE
- K Number
- K113839
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Parkell, Inc.
- Date Received
- December 28, 2011
- Decision Date
- April 12, 2012
- Product Code
- MVL
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| MVL | Cord, Retraction | FDA unclassified | Unknown |
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