FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BERRY FRUITY TEETHER
K Number: K053493
·
Decision Feb 22, 2006
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
26
Applicant Total
8
Review Days
69
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- BERRY FRUITY TEETHER
- K Number
- K053493
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.5550
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Evenflo Company, Inc.
- Date Received
- December 15, 2005
- Decision Date
- February 22, 2006
- Product Code
- KKO
- 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 |
|---|---|---|---|
| KKO | Ring, Teething, Fluid-Filled | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KKO), ordered by most recent decision date.
WATER-FILLED TEETHER
FDA 510(k)
FDA Class 2
·Dental
WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE
FDA 510(k)
FDA Class 2
·Dental
FLUID FILLED TEETHER - GEL
FDA 510(k)
FDA Class 2
·Dental
MAM COOLER
FDA 510(k)
FDA Class 2
·Dental
MAM TWISTER
FDA 510(k)
FDA Class 2
·Dental
GEL FILLED GUM SOOTHER
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Evenflo Company, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K102600 | SIMPLYGO BREAST PUMP | Dec 22, 2010 | Substantially Equivalent |
| K100435 | AMEDA PLATINUM BREAST PUMP | May 28, 2010 | Substantially Equivalent |
| K092770 | SIMPLYGO HANDS FREE BREAST PUMP | Oct 9, 2009 | Substantially Equivalent |
| K082307 | EVENFLO COMFORT SELECT PERFORMANCE BREAST PUMP KIT | Sep 11, 2008 | Substantially Equivalent |
| K052909 | EVENFLO ELAN BREAST PUMP | Nov 1, 2005 | Substantially Equivalent |
| K022933 | EVENFLO COMFORT SELECT AUTO-CYCLE BREAST PUMP KIT | Dec 2, 2002 | Substantially Equivalent |
| K013226 | EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT | Dec 20, 2001 | Substantially Equivalent |