The following data is part of a premarket notification filed by Tutogen Medical U.s., Inc. with the FDA for Tutodent Dental Membrane.
| Device ID | K073097 |
| 510k Number | K073097 |
| Device Name: | TUTODENT DENTAL MEMBRANE |
| Classification | Barrier, Animal Source, Intraoral |
| Applicant | TUTOGEN MEDICAL U.S., INC. 13709 PROGRESS BLVD. BOX 19 SOUTH WING Alachua, FL 32615 |
| Contact | Travis Arola |
| Correspondent | Travis Arola TUTOGEN MEDICAL U.S., INC. 13709 PROGRESS BLVD. BOX 19 SOUTH WING Alachua, FL 32615 |
| Product Code | NPL |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-01 |
| Decision Date | 2008-05-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04041543305487 | K073097 | 000 |
| 04041543305470 | K073097 | 000 |
| 04041543305463 | K073097 | 000 |