The following data is part of a premarket notification filed by Medical Monofilament Manufacturing with the FDA for Medical Monofilament Sensory Screening Toool.
| Device ID | K143068 |
| 510k Number | K143068 |
| Device Name: | Medical Monofilament Sensory Screening Toool |
| Classification | Esthesiometer |
| Applicant | Medical Monofilament Manufacturing 121 Camelot Drive Plymouth, MA 02360 |
| Contact | Michelle Hardiman |
| Correspondent | Susan Hamann Alvamed, Inc. 21 Phillip Ave Burlington, MA 01803 |
| Product Code | GXB |
| CFR Regulation Number | 882.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-24 |
| Decision Date | 2015-01-14 |
| Summary: | summary |