MEDCARE SUTURE SCISSORS (SUTURE/GAUZE WEIGHT)
FDA 510(k) clearance K861806 · decided 1986-05-23
Clearance details
- K-number
- K861806
- Device name
- MEDCARE SUTURE SCISSORS (SUTURE/GAUZE WEIGHT)
- Applicant
- Medcomp Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-05-09
- Decision date
- 1986-05-23
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- KDA
- Device class
- 2
- Regulation number
- 878.3500
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Penfield, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.