The following data is part of a premarket notification filed by Moyco Industries, Inc. with the FDA for Spotar.
Device ID | K810839 |
510k Number | K810839 |
Device Name: | SPOTAR |
Classification | Material, Impression |
Applicant | MOYCO INDUSTRIES, INC. 803 N. Front St. Suite 3 McHenry, IL 60050 |
Product Code | ELW |
CFR Regulation Number | 872.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-03-27 |
Decision Date | 1981-04-29 |