BIOMEND EXTEND ABSORBABLE COLLAGEN MEMBRANE, BIOMEND ABSORBABLE COLLAGEN MENBRANE

Bone Grafting Material, Synthetic

INTEGRA LIFESCIENCES CORP.

The following data is part of a premarket notification filed by Integra Lifesciences Corp. with the FDA for Biomend Extend Absorbable Collagen Membrane, Biomend Absorbable Collagen Menbrane.

Pre-market Notification Details

Device IDK992216
510k NumberK992216
Device Name:BIOMEND EXTEND ABSORBABLE COLLAGEN MEMBRANE, BIOMEND ABSORBABLE COLLAGEN MENBRANE
ClassificationBone Grafting Material, Synthetic
Applicant INTEGRA LIFESCIENCES CORP. 105 MORGAN LN. Plainsboro,  NJ  08536
ContactJudith E O'grady
CorrespondentJudith E O'grady
INTEGRA LIFESCIENCES CORP. 105 MORGAN LN. Plainsboro,  NJ  08536
Product CodeLYC  
CFR Regulation Number872.3930 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-07-01
Decision Date1999-07-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00841336100879 K992216 000
30381780070768 K992216 000
30381780070782 K992216 000
30381780038515 K992216 000
30381780038522 K992216 000
30381780038539 K992216 000
30381780072601 K992216 000
30381780072618 K992216 000
30381780072625 K992216 000
00841336100855 K992216 000
00841336100862 K992216 000
30381780070744 K992216 000

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