PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE; AND PASSING NEEDLE WITH ETHIBOND LOOP
FDA 510(k) clearance K041806 · decided 2004-08-03
Clearance details
- K-number
- K041806
- Device name
- PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE; AND PASSING NEEDLE WITH ETHIBOND LOOP
- Applicant
- Depuy Mitek, A Johnson & Johnson Company
- Decision
- Substantially Equivalent
- Date received
- 2004-07-06
- Decision date
- 2004-08-03
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- GAM
- Device class
- 2
- Regulation number
- 878.4493
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Norwood, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.