The following data is part of a premarket notification filed by Desco Industries, Inc. with the FDA for Tens Lead.
Device ID | K873608 |
510k Number | K873608 |
Device Name: | TENS LEAD |
Classification | Stimulator, Neuromuscular, External Functional |
Applicant | DESCO INDUSTRIES, INC. 761 PENARTH AVE. Walnut, CA 91789 |
Contact | Jeff B Reich |
Correspondent | Jeff B Reich DESCO INDUSTRIES, INC. 761 PENARTH AVE. Walnut, CA 91789 |
Product Code | GZI |
CFR Regulation Number | 882.5810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-08 |
Decision Date | 1987-09-30 |