The following data is part of a premarket notification filed by Micro Current Technology, Inc. with the FDA for Med-4000.
Device ID | K993823 |
510k Number | K993823 |
Device Name: | MED-4000 |
Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
Applicant | MICRO CURRENT TECHNOLOGY, INC. 4822 CALIFORNIA AVE., S.W., SUITE 201 Seattle, WA 98116 |
Contact | James Y Suzuki |
Correspondent | Robert M Boonstra UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
Product Code | GZJ |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 1999-11-12 |
Decision Date | 1999-11-19 |