ATRIUM MEDICAL CORPORATION ADVANTA PTFE FACIAL IMPLANT

Mesh, Surgical, Polymeric

ATRIUM MEDICAL CORP.

The following data is part of a premarket notification filed by Atrium Medical Corp. with the FDA for Atrium Medical Corporation Advanta Ptfe Facial Implant.

Pre-market Notification Details

Device IDK992991
510k NumberK992991
Device Name:ATRIUM MEDICAL CORPORATION ADVANTA PTFE FACIAL IMPLANT
ClassificationMesh, Surgical, Polymeric
Applicant ATRIUM MEDICAL CORP. 5 WENTWORTH DR. Hudson,  NH  03051
ContactKaren Hall
CorrespondentKaren Hall
ATRIUM MEDICAL CORP. 5 WENTWORTH DR. Hudson,  NH  03051
Product CodeFTL  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-09-07
Decision Date2000-01-27

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