COLLA-TEC ABSORBABLE COLLAGEN MEMBRANE— 510(k) K924408
Substantially EquivalentColla-Tec, Inc.
FDA 510(k) clearance K924408 for COLLA-TEC ABSORBABLE COLLAGEN MEMBRANE, Substantially Equivalent on 1995-08-22. Applicant: Colla-Tec, Inc.. Device class: 2.
Clearance details
- Applicant
- Colla-Tec, Inc.
- Product code
- Code LYC
- Device class
- Class 2
- Regulation
- 21 CFR 872.3930
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plainsboro, NJ, US
Recent devices under product code LYC
view allRecalls naming K924408
K-number listed on FDA's recall record- Z-1298-2013 — OraMem Absorbable Collagen Membrane OraMem¿ Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus.
- Z-1301-2013 — BioMend Absorbable Collagen Membrane BioMend¿ Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K924408.
Data sourced from openFDA. This site is unofficial and independent of the FDA.