The following data is part of a premarket notification filed by Peter Martin Associates, Inc. with the FDA for Svensk Tk/2.
Device ID | K820503 |
510k Number | K820503 |
Device Name: | SVENSK TK/2 |
Classification | Toothbrush, Powered |
Applicant | PETER MARTIN ASSOCIATES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JEQ |
CFR Regulation Number | 872.6865 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-02-25 |
Decision Date | 1982-03-19 |