The following data is part of a premarket notification filed by Delta Marketing, Inc. with the FDA for Ds-200 And Ds-400 T.e.n.s..
Device ID | K881832 |
510k Number | K881832 |
Device Name: | DS-200 AND DS-400 T.E.N.S. |
Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
Applicant | DELTA MARKETING, INC. 428 EAST SIDE BLVD. Muskogee, OK 74403 |
Contact | David R Waters |
Correspondent | David R Waters DELTA MARKETING, INC. 428 EAST SIDE BLVD. Muskogee, OK 74403 |
Product Code | GZJ |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-04-29 |
Decision Date | 1988-07-01 |