The following data is part of a premarket notification filed by Imtec Corp. with the FDA for Imtec Biobarrier Membrane.
Device ID | K972240 |
510k Number | K972240 |
Device Name: | IMTEC BIOBARRIER MEMBRANE |
Classification | Barrier, Synthetic, Intraoral |
Applicant | IMTEC CORP. 2401 NORTH COMMERCE Ardmore, OK 73401 |
Contact | M.k. Patterson |
Correspondent | M.k. Patterson IMTEC CORP. 2401 NORTH COMMERCE Ardmore, OK 73401 |
Product Code | NPK |
CFR Regulation Number | 872.3930 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-06-16 |
Decision Date | 1997-08-26 |
Summary: | summary |