Atlas FDA

COLLA-TEC ABSORBABLE COLLAGEN MEMBRANE

FDA 510(k) clearance K924408 · decided 1995-08-22

Clearance details

K-number
K924408
Device name
COLLA-TEC ABSORBABLE COLLAGEN MEMBRANE
Applicant
Colla-Tec, Inc.
Decision
Substantially Equivalent
Date received
1992-09-01
Decision date
1995-08-22
Days to decision
1085 days
Clearance type
Traditional
Product code
LYC
Device class
2
Regulation number
872.3930
Medical specialty
Dental
Advisory committee
Dental
Location
Plainsboro, NJ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
OraMem Absorbable Collagen Membrane OraMem Absorbable Collagen Membrane is an absorbable, recall (Z-1298-2013)Integra LifeSciences Corporation2013-05-10
BioMend Absorbable Collagen Membrane BioMend Absorbable Collagen Membrane is an absorbable recall (Z-1301-2013)Integra LifeSciences Corporation2013-05-10