BABY SNOOPY WATER FILLED TEETHER, MODEL 95367
FDA 510(k) clearance K052513 · decided 2006-06-28
Clearance details
- K-number
- K052513
- Device name
- BABY SNOOPY WATER FILLED TEETHER, MODEL 95367
- Applicant
- Delta Enterprise Corporation
- Decision
- Substantially Equivalent
- Date received
- 2005-09-14
- Decision date
- 2006-06-28
- Days to decision
- 287 days
- Clearance type
- Traditional
- Product code
- KKO
- Device class
- 2
- Regulation number
- 872.5550
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- New York, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.