TRUSYNTH, ABSORBABLE (POLYGLACTIN 910) SUTURE
FDA 510(k) clearance K081003 · decided 2008-06-09
Clearance details
- K-number
- K081003
- Device name
- TRUSYNTH, ABSORBABLE (POLYGLACTIN 910) SUTURE
- Applicant
- Sutures India Pvt., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2008-04-08
- Decision date
- 2008-06-09
- Days to decision
- 62 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
- Bangalore, IN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.