The following data is part of a premarket notification filed by Orthopedic Systems, Inc. with the FDA for Aesthesiometer.
Device ID | K874300 |
510k Number | K874300 |
Device Name: | AESTHESIOMETER |
Classification | Discriminator, Two-point |
Applicant | ORTHOPEDIC SYSTEMS, INC. 1897 NATIONAL AVE. Hayward, CA 94545 |
Contact | Roberty R Moore |
Correspondent | Roberty R Moore ORTHOPEDIC SYSTEMS, INC. 1897 NATIONAL AVE. Hayward, CA 94545 |
Product Code | GWI |
CFR Regulation Number | 882.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-10-20 |
Decision Date | 1987-11-06 |