DEMETECH STERILE SYNTHETIC ABSORBABLE SUTURES (PGA) AND NEEDLES
FDA 510(k) clearance K043539 · decided 2005-04-06
Clearance details
- K-number
- K043539
- Device name
- DEMETECH STERILE SYNTHETIC ABSORBABLE SUTURES (PGA) AND NEEDLES
- Applicant
- Demetech Corp.
- Decision
- Substantially Equivalent
- Date received
- 2004-12-22
- Decision date
- 2005-04-06
- Days to decision
- 105 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
- Appollo Beach, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.