SURG-A-STAT LOOP TIP 2
FDA 510(k) clearance K840387 · decided 1984-07-23
Clearance details
- K-number
- K840387
- Device name
- SURG-A-STAT LOOP TIP 2
- Applicant
- Suncoast Medical Manufacturers, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-01-30
- Decision date
- 1984-07-23
- Days to decision
- 175 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.