The following data is part of a premarket notification filed by Katecho, Inc. with the FDA for K-disperse.
Device ID | K921679 |
510k Number | K921679 |
Device Name: | K-DISPERSE |
Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
Applicant | KATECHO, INC. 2601 BELL AVE. P.O BOX 21247 Des Moines, IA 50315 |
Contact | Lorne Scharnberg |
Correspondent | Lorne Scharnberg KATECHO, INC. 2601 BELL AVE. P.O BOX 21247 Des Moines, IA 50315 |
Product Code | GZJ |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-04-08 |
Decision Date | 1992-10-06 |