S-SCORT...JR QUICKDRAW, MODEL 2400
FDA 510(k) clearance K041154 · decided 2004-05-18
Clearance details
- K-number
- K041154
- Device name
- S-SCORT...JR QUICKDRAW, MODEL 2400
- Applicant
- Sscor
- Decision
- Substantially Equivalent
- Date received
- 2004-05-03
- Decision date
- 2004-05-18
- Days to decision
- 15 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
- Sun Valley, CA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.