Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026)
FDA 510(k) clearance K242028 · decided 2024-11-19
Clearance details
- K-number
- K242028
- Device name
- Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026)
- Applicant
- Dongguanshi Yiyingmei Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2024-07-11
- Decision date
- 2024-11-19
- Days to decision
- 131 days
- Clearance type
- Traditional
- Product code
- BTA
- Device class
- 2
- Regulation number
- 878.4780
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Dongguan, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.