RPM Reinforced PTFE Mesh

Barrier, Synthetic, Intraoral

Osteogenics Biomedical, Inc.

The following data is part of a premarket notification filed by Osteogenics Biomedical, Inc. with the FDA for Rpm Reinforced Ptfe Mesh.

Pre-market Notification Details

Device IDK171774
510k NumberK171774
Device Name:RPM Reinforced PTFE Mesh
ClassificationBarrier, Synthetic, Intraoral
Applicant Osteogenics Biomedical, Inc. 4620 71st St. Bldg. 78-79 Lubbock,  TX  79424
ContactShane Shuttlesworth
CorrespondentShane Shuttlesworth
Osteogenics Biomedical, Inc. 4620 71st St. Bldg. 78-79 Lubbock,  TX  79424
Product CodeNPK  
CFR Regulation Number872.3930 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-06-14
Decision Date2017-10-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
DR65RPM250XLM20 K171774 000
D765RPM250XLKM0 K171774 000
D765RPM250XLKM20 K171774 000
D765RPM250PTCM20 K171774 000
D765RPM250PTCM0 K171774 000
D765RPM250PSTM30 K171774 000
D765RPM250PSM20 K171774 000
D765RPM250PLTM30 K171774 000
D765RPM250PLM20 K171774 000
D765RPM250PDMR0 K171774 000
D765RPM250PDML0 K171774 000
D765RPM250PDM20 K171774 000
D765RPM250K2M20 K171774 000
D765RPM250BLM20 K171774 000
D765RPM250ATCM20 K171774 000
D765RPM250ATCM0 K171774 000
D765RPM200BLL0 K171774 000
D765RPM200ATC0 K171774 000
D765RPM200XLKM0 K171774 000
D765RPM200XLK0 K171774 000
D765RPM200XL0 K171774 000
D765RPM200PTCM0 K171774 000
D765RPM200PTC0 K171774 000
D765RPM200PST0 K171774 000
D765RPM200PS0 K171774 000
D765RPM200PLT0 K171774 000
D765RPM200PL0 K171774 000
D765RPM200PDMR0 K171774 000
D765RPM200PDML0 K171774 000
D765RPM200PD0 K171774 000
D765RPM200K20 K171774 000
D765RPM200BL0 K171774 000
D765RPM200ATCM0 K171774 000
D765RPM250XLM20 K171774 000

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