SPONGETRAC
FDA 510(k) clearance K964181 · decided 1997-02-26
Clearance details
- K-number
- K964181
- Device name
- SPONGETRAC
- Applicant
- Surgitrac Corp.
- Decision
- Substantially Equivalent
- Date received
- 1996-10-18
- Decision date
- 1997-02-26
- Days to decision
- 131 days
- Clearance type
- Traditional
- Product code
- MRL
- Device class
- 1
- Regulation number
- 880.2740
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.