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 ID: K171774
• 510k Number: K171774
• Device Name: RPM Reinforced PTFE Mesh
• Classification: Barrier, Synthetic, Intraoral
• Applicant: Osteogenics Biomedical, Inc. 4620 71st St. Bldg. 78-79 Lubbock, TX 79424
• Contact: Shane Shuttlesworth
• Correspondent: Shane Shuttlesworth; Osteogenics Biomedical, Inc. 4620 71st St. Bldg. 78-79 Lubbock, TX 79424
• Product Code: NPK
• CFR Regulation Number: 872.3930 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-06-14
• Decision Date: 2017-10-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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