The following data is part of a premarket notification filed by Macropore Biosurgery, Inc. with the FDA for Macropore Ent Reconstruction Film.
| Device ID | K012769 |
| 510k Number | K012769 |
| Device Name: | MACROPORE ENT RECONSTRUCTION FILM |
| Classification | Polymer, Ear, Nose And Throat, Synthetic, Absorbable |
| Applicant | MACROPORE BIOSURGERY, INC. 6740 TOP GUN ST. San Diego, CA 92121 |
| Contact | Kenneth K Kleinhenz |
| Correspondent | Kenneth K Kleinhenz MACROPORE BIOSURGERY, INC. 6740 TOP GUN ST. San Diego, CA 92121 |
| Product Code | NHB |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-17 |
| Decision Date | 2001-10-25 |
| Summary: | summary |